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. 2021 Oct 22;10(10):CD015025.
doi: 10.1002/14651858.CD015025.

Antibiotics for the treatment of COVID-19

Maria Popp  1 , Miriam Stegemann  2 , Manuel Riemer  1 , Maria-Inti Metzendorf  3 , Carolina S Romero  4 , Agata Mikolajewska  2 , Peter Kranke  1 , Patrick Meybohm  1 , Nicole Skoetz  5 , Stephanie Weibel  1
Affiliations

Antibiotics for the treatment of COVID-19

Maria Popp et al. Cochrane Database Syst Rev. .

Abstract

Background: The effect of antibiotics with potential antiviral and anti-inflammatory properties are being investigated in clinical trials as treatment for COVID-19. The use of antibiotics follows the intention-to-treat the viral disease and not primarily to treat bacterial co-infections of individuals with COVID-19. A thorough understanding of the current evidence regarding effectiveness and safety of antibiotics as anti-viral treatments for COVID-19 based on randomised controlled trials (RCTs) is required.

Objectives: To assess the efficacy and safety of antibiotics compared to each other, no treatment, standard of care alone, placebo, or any other active intervention with proven efficacy for treatment of COVID-19 outpatients and inpatients. SEARCH METHODS: We searched the Cochrane COVID-19 Study Register (including MEDLINE, Embase, ClinicalTrials.gov, WHO ICTRP, medRxiv, CENTRAL), Web of Science and WHO COVID-19 Global literature on coronavirus disease to identify completed and ongoing studies to 14 June 2021.

Selection criteria: RCTs were included that compared antibiotics with each other, no treatment, standard of care alone, placebo, or another proven intervention, for treatment of people with confirmed COVID-19, irrespective of disease severity, treated in the in- or outpatient settings. Co-interventions had to be the same in both study arms. We excluded studies comparing antibiotics to other pharmacological interventions with unproven efficacy.

Data collection and analysis: We assessed risk of bias of primary outcomes using the Cochrane risk of bias tool (ROB 2) for RCTs. We used GRADE to rate the certainty of evidence for the following primary outcomes: 1. to treat inpatients with moderate to severe COVID-19: mortality, clinical worsening defined as new need for intubation or death, clinical improvement defined as being discharged alive, quality of life, adverse and serious adverse events, and cardiac arrhythmias; 2. to treat outpatients with asymptomatic or mild COVID-19: mortality, clinical worsening defined as hospital admission or death, clinical improvement defined as symptom resolution, quality of life, adverse and serious adverse events, and cardiac arrhythmias.

Main results: We included 11 studies with 11,281 participants with an average age of 54 years investigating antibiotics compared to placebo, standard of care alone or another antibiotic. No study was found comparing antibiotics to an intervention with proven efficacy. All studies investigated azithromycin, two studies investigated other antibiotics compared to azithromycin. Seven studies investigated inpatients with moderate to severe COVID-19 and four investigated mild COVID-19 cases in outpatient settings. Eight studies had an open-label design, two were blinded with a placebo control, and one did not report on blinding. We identified 19 ongoing and 15 studies awaiting classification pending publication of results or clarification of inconsistencies. Of the 30 study results contributing to primary outcomes by included studies, 17 were assessed as overall low risk and 13 as some concerns of bias. Only studies investigating azithromycin reported data eligible for the prioritised primary outcomes. Azithromycin doses and treatment duration varied among included studies. Azithromycin for the treatment of COVID-19 compared to placebo or standard of care alone in inpatients We are very certain that azithromycin has little or no effect on all-cause mortality at day 28 compared to standard of care alone (risk ratio (RR) 0.98; 95% confidence interval (CI) 0.90 to 1.06; 8600 participants; 4 studies; high-certainty evidence). Azithromycin probably has little or no effect on clinical worsening or death at day 28 (RR 0.95; 95% CI 0.87 to 1.03; 7311 participants; 1 study; moderate-certainty evidence), on clinical improvement at day 28 (RR 0.96; 95% CI 0.84 to 1.11; 8172 participants; 3 studies; moderate-certainty evidence), on serious adverse events during the study period (RR 1.11; 95% CI 0.89 to 1.40; 794 participants; 4 studies; moderate-certainty evidence), and cardiac arrhythmias during the study period (RR 0.92; 95% CI 0.73 to 1.15; 7865 participants; 4 studies; moderate-certainty evidence) compared to placebo or standard of care alone. Azithromycin may increase any adverse events slightly during the study period (RR 1.20; 95% CI 0.92 to 1.57; 355 participants; 3 studies; low-certainty evidence) compared to standard of care alone. No study reported quality of life up to 28 days. Azithromycin for the treatment of COVID-19 compared to placebo or standard of care alone in outpatients Azithromycin may have little or no effect compared to placebo or standard of care alone on all-cause mortality at day 28 (RR 1.00 ; 95% CI 0.06 to 15.69; 876 participants; 3 studies; low-certainty evidence), on admission to hospital or death within 28 days (RR 0.94 ; 95% CI 0.57 to 1.56; 876 participants; 3 studies; low-certainty evidence), and on symptom resolution at day 14 (RR 1.03; 95% CI 0.95 to 1.12; 138 participants; 1 study; low-certainty evidence). We are uncertain whether azithromycin increases or reduces serious adverse events compared to placebo or standard of care alone (0 participants experienced serious adverse events; 454 participants; 2 studies; very low-certainty evidence). No study reported on adverse events, cardiac arrhythmias during the study period or quality of life up to 28 days. Azithromycin for the treatment of COVID-19 compared to any other antibiotics in inpatients and outpatients One study compared azithromycin to lincomycin in inpatients, but did not report any primary outcome. Another study compared azithromycin to clarithromycin in outpatients, but did not report any relevant outcome for this review.

Authors' conclusions: We are certain that risk of death in hospitalised COVID-19 patients is not reduced by treatment with azithromycin after 28 days. Further, based on moderate-certainty evidence, patients in the inpatient setting with moderate and severe disease probably do not benefit from azithromycin used as potential antiviral and anti-inflammatory treatment for COVID-19 regarding clinical worsening or improvement. For the outpatient setting, there is currently low-certainty evidence that azithromycin may have no beneficial effect for COVID-19 individuals. There is no evidence from RCTs available for other antibiotics as antiviral and anti-inflammatory treatment of COVID-19. With accordance to the living approach of this review, we will continually update our search and include eligible trials to fill this evidence gap. However, in relation to the evidence for azithromycin and in the context of antimicrobial resistance, antibiotics should not be used for treatment of COVID-19 outside well-designed RCTs.

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Conflict of interest statement

Maria Popp (MP) is funded by the Federal Ministry of Education and Research, Germany (NaFoUniMedCovid19, funding number: 01KX2021; part of the CEOsys project, which was paid to the institution).

Miriam Stegemann (MS) has no known conflicts of interest to declare.

Manuel Riemer (MR) has no known conflicts of interest to declare.

Maria‐Inti Metzendorf (MIM) has no known conflicts of interest to declare.

Carolina Romero (CR) has no known conflicts of interest to declare.

Agata Mikolajewska (AM) has no known conflicts of interest to declare.

Peter Kranke (PK) received intuitional funding by the CEOsys project.

Patrick Meybohm (PM) received intuitional funding by the CEOsys project.

Nicole Skoetz (NS) has no known conflicts of interest to declare.

Stephanie Weibel (SW) is funded by the Federal Ministry of Education and Research, Germany (NaFoUniMedCovid19, funding number: 01KX2021; part of the CEOsys project, which was paid to the institution).

Figures

1
1
1.1
1.1. Analysis
Comparison 1: Azithromycin compared to placebo or standard of care for inpatients with confirmed moderate to severe COVID‐19, Outcome 1: All‐cause mortality at day 28
1.2
1.2. Analysis
Comparison 1: Azithromycin compared to placebo or standard of care for inpatients with confirmed moderate to severe COVID‐19, Outcome 2: Worsening of clinical status: participants with clinical deterioration (new need for invasive mechanical ventilation) or death at day 28
1.3
1.3. Analysis
Comparison 1: Azithromycin compared to placebo or standard of care for inpatients with confirmed moderate to severe COVID‐19, Outcome 3: Improvement of clinical status: participants discharged alive at day 28
1.4
1.4. Analysis
Comparison 1: Azithromycin compared to placebo or standard of care for inpatients with confirmed moderate to severe COVID‐19, Outcome 4: Serious adverse events during the study period, defined as number of participants with any event
1.5
1.5. Analysis
Comparison 1: Azithromycin compared to placebo or standard of care for inpatients with confirmed moderate to severe COVID‐19, Outcome 5: Adverse events (any grade) during the study period, defined as number of participants with any event
1.6
1.6. Analysis
Comparison 1: Azithromycin compared to placebo or standard of care for inpatients with confirmed moderate to severe COVID‐19, Outcome 6: Cardiac arrhythmias during the study period
2.1
2.1. Analysis
Comparison 2: Azithromycin compared to placebo or standard of care for outpatients with confirmed asymptomatic or mild COVID‐19, Outcome 1: All‐cause mortality at day 28
2.2
2.2. Analysis
Comparison 2: Azithromycin compared to placebo or standard of care for outpatients with confirmed asymptomatic or mild COVID‐19, Outcome 2: Admission to hospital or death within 28 days
2.3
2.3. Analysis
Comparison 2: Azithromycin compared to placebo or standard of care for outpatients with confirmed asymptomatic or mild COVID‐19, Outcome 3: All initial symptoms resolved (asymptomatic) at day 14
2.4
2.4. Analysis
Comparison 2: Azithromycin compared to placebo or standard of care for outpatients with confirmed asymptomatic or mild COVID‐19, Outcome 4: All initial symptoms resolved (asymptomatic) at day 28
2.5
2.5. Analysis
Comparison 2: Azithromycin compared to placebo or standard of care for outpatients with confirmed asymptomatic or mild COVID‐19, Outcome 5: Serious adverse events during the study period, defined as number of participants with any event
See this image and copyright information in PMC

References

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    1. NCT04371406. Efficacy of azithromycin-associated hydroxychloroquine therapy given in general practice in early-stage disease in COVID-19 patients (MG-COVID). clinicaltrials.gov/ct2/show/NCT04371406 (first received 1 May 2020).
NCT04373733 {published data only}
    1. Chelsea, Westminster N H S Foundation Trust. A randomised controlled trial of early intervention in patients hospItalised with COVID-19: favipiravir verses hydroxycholorquine & azithromycin & zinc verses standard care. www.clinicaltrialsregister.eu/ctr-search/trial/2020-001449-38/GB (first received 17 May 2020).
    1. NCT04373733. A randomised controlled trial of early intervention in COVID-19: favipiravir verses hydroxycholorquine & azithromycin & zinc verses standard care (PIONEER). clinicaltrials.gov/ct2/show/NCT04373733 (first received 4 May 2020).
NCT04374019 {published data only}
    1. NCT04374019. Novel agents for treatment of high-risk COVID-19 positive patients. clinicaltrials.gov/ct2/show/NCT04374019 (first received 5 May 2020).
NCT04374552 {published data only}
    1. NCT04374552. Asymptomatic COVID-19 Trial (ACT). clinicaltrials.gov/ct2/show/NCT04374552 (first received 5 May 2020).
NCT04374903 {published data only}
    1. NCT04374903. Hydroxychloroquine in combination with azithromycin or sirolimus for treating COVID-19 patients (COVID19-HOPE). clinicaltrials.gov/ct2/show/NCT04374903 (first received 5 May 2020).
NCT04382846 {published data only}
    1. NCT04382846. Novel regimens in COVID-19 treatment. clinicaltrials.gov/ct2/show/NCT04382846 (first received 11 May 2020).
NCT04390594 {published data only}
    1. NCT04390594. Efficacy and safety evaluation of treatment regimens in adult COVID-19 patients in Senegal (SEN-CoV-Fadj). clinicaltrials.gov/ct2/show/NCT04390594 (first received 15 May 2020).
NCT04392128 {published data only}
    1. NCT04392128. Study evaluating the efficacy of hydroxychloroquine and azithromycine inpatients with COVID-19 and hematological malignancies (HYACINTHE). clinicaltrials.gov/ct2/show/NCT04392128 (first received 18 May 2020).
NCT04395768 {published data only}
    1. ACTRN12620000557932. International ALLIANCE study of therapies to prevent progression of COVID-19, a randomized trial. anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000557932 (first 8 May 2020).
    1. NCT04395768. International ALLIANCE Study of therapies to prevent progression of COVID-19. clinicaltrials.gov/ct2/show/study/NCT04395768 (first received 20 May 2020).
NCT04399746 {published data only}
    1. NCT04399746. Ivermectin-azithromycin-cholecalciferol (IvAzCol) combination therapy for COVID-19. clinicaltrials.gov/ct2/show/NCT04399746 (first received 22 May 2020).
NCT04403555 {published data only}
    1. NCT04403555. Ivermectin and doxycycline in COVID-19 treatment. clinicaltrials.gov/ct2/show/NCT04403555 (first received 27 May 2020).
NCT04407130 {published data only}
    1. NCT04407130. Efficacy and safety of ivermectin and doxycycline in combination or IVE alone in patients with COVID-19 infection. clinicaltrials.gov/ct2/show/study/NCT04407130 (first received 29 May 2020).
NCT04433078 {published data only}
    1. NCT04433078. RepurpoSing old drugs TO SuppRess a Modern threat: COVID-19 STORM. clinicaltrials.gov/ct2/show/study/NCT04433078 (first received 16 June 2020).
NCT04458948 {published data only}
    1. NCT04458948. Open label non-comparative trial of the combination of hydroxychloroquine and azithromycin in the treatment of hospitalized patients. clinicaltrials.gov/ct2/show/NCT04458948 (first received 7 July 2020).
NCT04459702 {published data only}
    1. NCT04459702. A study of combination therapies to treat COVID-19 infection. clinicaltrials.gov/ct2/show/NCT04459702 (first received 7 July 2020).
NCT04482686 {published data only}
    1. NCT04482686. Trial of combination therapy to treat COVID-19 infection. clinicaltrials.gov/ct2/show/NCT04482686 (first received 22 July 2020).
NCT04492501 {published data only}
    1. NCT04492501. Investigational treatments for COVID-19 in tertiary care hospital of Pakistan. clinicaltrials.gov/ct2/show/NCT04492501 (first received 30 July 2020).
NCT04551755 {published data only}
    1. NCT04551755. Safety and efficacy of ivermectin and doxycycline in treatment of Covid-19. clinicaltrials.gov/ct2/show/NCT04551755 (first received 16 September 2020).
NCT04575558 {published data only}
    1. NCT04575558. HOPE: a trial of Hydroxichloroquine plus azithromycin in high risk COVID-19 (HOPE_BRAZIL). clinicaltrials.gov/ct2/show/NCT04575558 (first received 5 October 2020).
NCT04621461 {published data only}
    1. NCT04621461. Hydroxychloroquine, azithromycin and zinc for the treatment of COVID-19 in theoOutpatient setting. clinicaltrials.gov/ct2/show/NCT04621461 (first received 9 November 2020).
NCT04699097 {published data only}
    1. NCT04699097. The effect of azithromycin use on conduction system of heart in COVID-19 positive children. clinicaltrials.gov/ct2/show/NCT04699097 (first received 7 January 2021).
NCT04715295 {published data only}
    1. NCT04715295. Safety and efficacy of doxycycline and rivaroxaban in COVID-19 (DOXYCOV). clinicaltrials.gov/ct2/show/NCT04715295 (first received 20 January 2021).
Okour 2020 {published data only}
    1. Okour M, Al-Kofahi M, Austin D. Hydroxychloroquine and azithromycin as potential treatments for COVID-19; clinical status impacts the outcome. Journal of Pharmacokinetics and Pharmacodynamics 2020;47:187-8. [DOI: 10.1007/s10928-020-09689-x] - DOI - PMC - PubMed
PACTR202005622389003 {published data only}
    1. PACTR202005622389003. Hydroxychloroquine, azithromycine and zinc for the treatment of SARS-Cov2 infection in Senegal. COVID-19. https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=11053 (first received 28 May 2020).
RBR‐3k4wxb {published data only}
    1. RBR-3k4wxb. Evaluation of the use of hydroxychlorochine in Chinese flu. ensaiosclinicos.gov.br/rg/RBR-3k4wxb/ (first received 5 May 2020).
RBR‐3rywwg {published data only}
    1. RBR-3rywwg. A clinical, randomized study to evaluate the efficacy and safety of Naproxen compared to placebo in combination with azithromycin or levofloxacin in patients with Severe Acute Respiratory Syndrome during the Covid-19 pandemic. ensaiosclinicos.gov.br/rg/RBR-3rywwg (first received 10 July 2020).
RBR‐7nzwkpg {published data only}
    1. RBR-7nzwkpg. Effects of treatment with oral anticoagulant associated with antibiotics on clinical, immunological, hospitalization and death parameters in patients with suspected Covid-19 infection and coagulation disorders. ensaiosclinicos.gov.br/trial/10336 (first received 6 January 2021).
RBR‐95yjmq {published data only}
    1. RBR-95yjmq. Placebo-controlled clinical trial to evaluate the efficacy and safety of hydroxychloroquine and azithromycin in relation to placebo in the negative viral load of participants with SARS-CoV2 flu syndrome and who do not have an indication for hospitalization. ensaiosclinicos.gov.br/rg/RBR-95yjmq (first received 29 April 2020).
Sivapalan 2020 {published data only}
    1. 2020-001198-55/DK. Proactive prophylaxis with azithromycin andhHydroxychloroquine patients hospitalized with COVID. www.clinicaltrialsregister.eu/ctr-search/trial/2020-001198-55/DK (first received 21 March 2020).
    1. NCT04322396. Proactive Protection With Azithromycin and hydroxyChloroquine in hospitalized Patients with COVID-19 (ProPAC-COVID). clinicaltrials.gov/ct2/show/NCT04322396 (first received 26 May 2020).
    1. Sivapalan P, Ulrik CS, Bojesen RD, Lapperre TS, Eklof JV, Hakansson KEJ et al. Proactive prophylaxis with azithromycin and hydroxychloroquine in hospitalised patients with COVID-19 (ProPAC-COVID): a structured summary of a study protocol for a randomised controlled trial. Trials 2020;21(1):513. [DOI: 10.1186/s13063-020-04409-9] - DOI - PMC - PubMed
    1. Sivapalan P, Ulrik CS, Lappere TS, Eklof JV, Shaker SB, Bodtger UC, et al. Proactive prophylaxis with azithromycin and hydroxychloroquine in hospitalized patients with COVID-19 (ProPAC-COVID): a statistical analysis plan. Trials 2020;21:867. [DOI: 10.1186/s13063-020-04795-0] - DOI - PMC - PubMed
    1. Sivapalan P, Ulrik CS, Lapperre TS, Bojesen RD, Eklof J, Browatzki A. Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19–a randomised double-blinded placebo-controlled trial. European Respiratory Journal (in press). [DOI: 10.1183/13993003.00752-2021] - DOI - PMC - PubMed
Spoorthi 2020 {published data only}
    1. Spoorthi V, Sasank S. Utility of ivermectin and doxycycline combination for the treatment of SARS-CoV-2. International Archives of Integrated Medicine 2020;7(10):177-82. [iaimjournal.com/wp-content/uploads/2020/10/iaim_2020_0710_23.pdf]
Tsiakos 2020 {published data only}
    1. 2020-001882-36/GR. Clarithromycin in COVID-19. www.clinicaltrialsregister.eu/ctr-search/trial/2020-001882-36/GR (first received 30 April 2020).
    1. NCT04398004. Anti-inflammatory clarithromycin for improving COVID-19 Infection Early (ACHIEVE). clinicaltrials.gov/ct2/show/NCT04398004 (first received 21 May 2020).
    1. Tsiakos K, Tsakiris A, Tsibris G, Voutsinas P, Panagopoulos P, Kosmidou M, et al. Oral clarithromycin in COVID-19 of moderate severity: the ACHIEVE open-label trial using concurrent matched comparators. medrxiv.org/content/10.1101/2020.12.22.20248753v1 (first posted 26 October 2020). [DOI: 10.1101/2020.12.22.20248753] - DOI

References to studies awaiting assessment

Duska 2020 {published data only}
    1. Duska F, Waldauf P, Halacova M, Zvonicek V, Bala J, Balik M, et al. Azithromycin added to hydroxychloroquine for patients admitted to intensive care due to coronavirus disease 2019 (COVID-19)-protocol of randomised controlled trial AZIQUINE-ICU. Trials 2020;21(1):631. [DOI: 10.1186/s13063-020-04566-x] - DOI - PMC - PubMed
    1. EUCTR-2020-001456-18/CZ. Azithromycin added to Hydrochloroquine in Patients Admitted to Intensive Care due to Coronavirus Disease 2019 (COVID-19)-Randomised Controlled Trial, phase III. www.clinicaltrialsregister.eu/ctr-search/trial/2020-001456-18/CZ (first received 8 April 2020).
    1. NCT04339816. Azithromycin Added to Hydrochloroquine in Patients Admitted to Intensive Care With COVID-19: Randomised Controlled Trial (AZIQUINE-ICU). clinicaltrials.gov/ct2/show/NCT04339816 (first received 9 April 2020).
EUCTR‐2020‐001156‐18/ES {published data only}
    1. 2020-001156-18/ES. Efficacy of different treatments in patients infected with COVID-19. www.clinicaltrialsregister.eu/ctr-search/trial/2020-001156-18/ES (first received 3 April 2020).
EUCTR‐2020‐001606‐33/ES {published data only}
    1. 2020-001606-33/ES. Randomized clinical trial to evaluate the efficacy of hydroxychloroquine associated or not with azithromycin as a treatment for COVID-19 infection. www.clinicaltrialsregister.eu/ctr-search/trial/2020-001606-33/ES (fist received 7 April 2020).
Feeney 2020 {published data only}
    1. EUCTR-2020-001265-36/IE. A trial to compare standard of care (SOC) alone with SOC plus hydroxychloroquine or SOC with a combination of hydroxycholorquine and azithromysin in the treatment of coronovirus. www.clinicaltrialsregister.eu/ctr-search/trial/2020-001265-36/IE (first received 7 April 2020).
    1. Feeney E, Wallace D, Cotter A, Tinago W, McCarthy C, Keane D, et al. The COVIRL-001 trial: a multicentre, prospective, randomised trial comparing standard of care (SOC) alone, SOC plus hydroxychloroquine monotherapy or SOC plus a combination of hydroxychloroquine and azithromycin in the treatment of non- critical, SARS-CoV-2 PCR-positive population not requiring immediate resuscitation or ventilation but who have evidence of clinical decline: a structured summary of a study protocol for a randomised controlled trial. Trials 2020;21(1):430. [DOI: 10.1186/s13063-020-04407-x] - DOI - PMC - PubMed
Gyselinck 2021 {published data only}
    1. EUCTR-2020-001614-38/BE. Covid-19: a randomized, open-label, adaptive, proof-of- concept clinical trial of new antiviral drug candidates against SARS-CoV-2. www.clinicaltrialsregister.eu/ctr-search/trial/2020-001243-15/BE (first received 27 March 2020).
    1. Gyselinck I, Liesenborgs L, Landeloos E, Belmans A, Verbeke G, Verhamme P, et al. Direct antivirals working against the novel coronavirus: azithromycin (DAWn-AZITHRO), a randomized, multicenter, open-label, adaptive, proof-of-concept clinical trial of new antivirals working against SARS-CoV-2-azithromycin trial. Trials 2021;22(1):126. [DOI: 10.1186/s13063-021-05033-x] - DOI - PMC - PubMed
IRCT20080901001165N50 {published data only}
    1. IRCT20080901001165N50. Investigating the efficacy and safety of azithromycin inhaled spray in controlling the symptoms of patients with COVID-19. en.irct.ir/trial/47576 (first received 1 May 2020).
IRCT20191211045691N2 {published data only}
    1. IRCT20191211045691N2. Evaluation of the efficacy and safety of doxycycline in combination with standard treatment in Covid-19 patients: a clinical trial. irct.ir/trial/51951 (first received 2 November 2020).
IRCT20200428047228N2 {published data only}
    1. IRCT20200428047228N2. Evaluation of the efficiency of hydroxychloroquine drug regimen in comparison with hydroxychloroquine + azithromycin in hospitalized patients with covid-19 in the intensive care unit. en.irct.ir/trial/48096 (first received 10 June 2020).
IRCT20200608047686N1 {published data only}
    1. IRCT20200608047686N1. Evaluation of therapeutic effects of metronidazole In inpatients with pneuomonia due to COVID-19. en.irct.ir/trial/48717 (first received 30 June 2020).
IRCT20200718048129N1 {published data only}
    1. IRCT20200718048129N1. Evaluation of the effectiveness of Hydroxychloroquine and Clarithromycin in dyspnea and caugh caused by COVID-19 in recovery phase. en.irct.ir/trial/49729 (first received 11 August 2020).
NCT04345861 {published data only}
    1. EUCTR-2020-001406-27/FR. Randomized open label trial assessing efficacy and safety of hydroxychloroquine plus azithromycin versus hydroxychloroquine for hospitalized patients with COVID-19. www.clinicaltrialsregister.eu/ctr-search/trial/2020-001406-27/FR (first received 3 April 2020).
    1. University Hospital Montpellier. Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for COVID-19 Pneumonia (COVIDOC Trial). clinicaltrials.gov/ct2/show/NCT04345861 (first received 15 April 2020).
NCT04370782 {published data only}
    1. NCT04370782. Hydroxychloroquine and Zinc With Either Azithromycin or Doxycycline for Treatment of COVID-19 in Outpatient Setting. clinicaltrials.gov/ct2/show/NCT04370782 (first received 1 May 2020).
Purwati 2021 {published data only}
    1. Purwati, Budiono, Rachman BE, Yulistiani, Miatmoko A, Nasronudin, et al. A Randomized, Double-Blind, Multicenter Clinical Study Comparing the Efficacy and Safety of a Drug Combination of Lopinavir/Ritonavir-Azithromycin, Lopinavir/Ritonavir-Doxycycline, and Azithromycin-Hydroxychloroquine for Patients Diagnosed with Mild to Mo. Biochemistry Research International 2021;2021:6685921. [DOI: 10.1155/2021/6685921] - DOI - PMC - PubMed
Sayed 2020 {published data only}
    1. Sayed AM, Khalaf AM, Abdelrahim MEA, Elgendy MO. Repurposing of some anti-infective drugs for COVID-19 treatment: A surveillance study supported by an in silico investigation. International Journal of Clinical Practice 17 December 2020 [Epub ahead of print]. [DOI: 10.1111/ijcp.13877] - DOI - PMC - PubMed
Yamamoto 2021 {published data only}
    1. jRCTs071210011. CAM (Clarithromycin) Effectivity for COVID-19 pneumonia which does not require oxygen administration; multicenter, randomized-controlled, open-label, 3-armed parallel group comparison, exploratory trial. https://jrct.niph.go.jp/latest-detail/jRCTs071210011 (first received 13 April 2021).
    1. Yamamoto K, Hosogaya N, Sakamoto N, Yoshida H, Ishii H, Yatera K, et al. Efficacy of clarithromycin on COVID-19 pneumonia without oxygen administration; protocol for multicenter, open-label, randomized-controlled, 3-armed parallel group comparison, exploratory trial (CAME COVID study). medrxiv.org/content/10.1101/2021.06.02.21258257v1.full-text (first posted 5 June 2021). [DOI: 10.1101/2021.06.02.21258257] - DOI

References to ongoing studies

Akram 2020 {published data only}
    1. Akram J, Azhar S, Shahzad M, Latif W, Khan KS. Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment (PROTECT) of hydroxychloroquine, oseltamivir and azithromycin to treat newly diagnosed patients with COVID-19 infection who have no comorbidities like diabetes mellitus: a structured summary of a study protocol for a randomized controlled trial. Trials 2020;21(1):702. [DOI: 10.1186/s13063-020-04616-4] - DOI - PMC - PubMed
    1. NCT04338698. Hydroxychloroquine, oseltamivir and azithromycin for the trreatment of COVID-19 Infection: an RCT (PROTECT). clinicaltrials.gov/ct2/show/NCT04338698 (first received 8 April 2020).
Angus 2020 {published data only}
    1. Angus DC, Berry S, Lewis RJ, Al-Beidh F, Arabi Y, Bentum-Puijk W, et al. The randomized embedded multifactorial adaptive platform for community-acquired pneumonia (REMAP-CAP) study: rationale and design. Annals of the American Thoracic Society 2020;17(7):879-91. [DOI: 10.1513/AnnalsATS.202003-192SD] - DOI - PMC - PubMed
    1. EUCTR-2015-002340-14. Adaptive trial in severe pneumonia (REMAP-CAP) - Version 23.0. www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:201... (first received 13 July 2020).
    1. ISRCTN67000769. An international platform trial for severely ill patients with community-acquired pneumonia or COVID-19. isrctn.com/ISRCTN67000769 (first received 9 July 2020).
    1. NCT02735707. Randomized, Embedded, Multifactorial Adaptive Platform trial for community- Acquired Pneumonia (REMAP-CAP) with sub-platform REMAP-COVID. clinicaltrials.gov/ct2/show/NCT02735707 (protocol for sub-platform REMAP-COVID first received 25 March 2020).
CTRI/2020/04/024904 {published data only}
    1. CTRI/2020/04/024904. Treatment of COVID19: a randomised controlled trial. ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=43130&EncHid=&am... (first received 28 April 2020).
CTRI/2020/10/028297 {published data only}
    1. CTRI/2020/10/028297. Cotrimoxazole in hospitalised patients with moderate to early-severe COVID-19 infection. ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=48268&EncHid=&am... (first received 8 October 2020).
EUCTR‐2020‐001527‐14/NL {published data only}
    1. EUCTR-2020-001527-14/NL. COVID-19: addition of azithromycin to chloroquine treatment. www.clinicaltrialsregister.eu/ctr-search/trial/2020-001527-14/NL (first received 6 April 2020).
NCT04328272 {published data only}
    1. NCT04328272. Effectiveness of hydroxychloroquine in Covid-19 patients. clinicaltrials.gov/ct2/show/study/NCT04328272 (first received 31 March 2020).
NCT04332107 {published data only}
    1. NCT04332107. Azithromycin for COVID-19 Treatment In Outpatients Nationwide (ACTION). clinicaltrials.gov/ct2/show/NCT04332107 (first 2 April 2020).
NCT04336332 {published data only}
    1. NCT04336332. Randomized comparison of combination azithromycin and hydroxychloroquine vs. hydroxychloroquine alone for the treatment of confirmed COVID-19. clinicaltrials.gov/ct2/show/NCT04336332 (first received 7 April 2020).
NCT04341727 {published data only}
    1. NCT04341727. Hydroxychloroquine, hydroxychloroquine, azithromycin in the treatment of SARS CoV-2 Infection (WU352). clinicaltrials.gov/ct2/show/NCT04341727 (first received 10 April 2020).
NCT04344444 {published data only}
    1. NCT04344444. Treatment in patients With suspected or confirmed COVID-19 with early moderate or severe disease (RCT). clinicaltrials.gov/ct2/show/NCT04344444 (first received 14 April 2020).
NCT04359316 {published data only}
    1. NCT04359316. Azithromycin in hospitalized COVID-19 patients. clinicaltrials.gov/ct2/show/NCT04359316 (first received 24 April 2020).
NCT04359953 {published data only}
    1. EUCTR-2020-001303-16/FR. Efficacy of hydroxychloroquine, telmisartan and azithromycin on survival in elderly hospitalized patients with VIDOC-19: a randomized, multi-centre, adaptive, blinded study. www.clinicaltrialsregister.eu/ctr-search/trial/2020-001303-16/FR (first received 29 March 2020).
    1. NCT04359953. Efficacy of hydroxychloroquine, telmisartan and azithromycin on the survival of hospitalized elderly patients with COVID-19 (COVID-Aging). clinicaltrials.gov/ct2/show/study/NCT04359953 (first received 24 April 2020).
NCT04363060 {published data only}
    1. NCT04363060. Azithromycin+amoxicillin/clavulanate vs amoxicillin/clavulanate in COVID19 patients with pneumonia in non-intensive unit (AziA). clinicaltrials.gov/ct2/show/NCT04363060 (first received 27 April 2020).
NCT04363203 {published data only}
    1. NCT04363203. VA Remote and Equitable Access to COVID-19 Healthcare delivery (VA-REACH TRIAL). clinicaltrials.gov/ct2/show/NCT04363203 (first received 27 April 2020).
NCT04371107 {published data only}
    1. NCT04371107. Proactive care of ambulatory COVID19 patients (AMBU-COVID). clinicaltrials.gov/ct2/show/NCT04371107 (first received 1 May 2020).
NCT04371952 {published data only}
    1. NCT04371952. DYNAMIC Study (DoxycYcliNe AMbulatoIre COVID-19). clinicaltrials.gov/ct2/show/NCT04371952 (first received 1 May 2020).
NCT04405921 {published data only}
    1. NCT04405921. Hydroxychloroquine, azithromycin in the treatment of Covid-19 (PACTT). clinicaltrials.gov/ct2/show/NCT04405921 (first received 28 May 2020).
NCT04470531 {published data only}
    1. NCT04470531. Role of co-trimoxazole in severe COVID-19 patients. clinicaltrials.gov/ct2/show/NCT04470531 (first received 14 July 2020).
NCT04729140 {published data only}
    1. NCT04729140. An outpatientc linical trial using ivermectin and doxycycline in COVID-19 positive patients at high risk to prevent COVID-19 related hospitalization. clinicaltrials.gov/ct2/show/NCT04729140 (first received 28 January 2021).

Additional references

Al‐Horani 2020
    1. Al-Horani RA, Kar S, Aliter KF. Potential anti-COVID-19 therapeutics that block the early stage of the viral life cycle: structures, mechanisms, and clinical trials. International Journal of Molecular Sciences 2020;21(15):2114. [DOI: 10.3390/ijms21155224] - DOI - PMC - PubMed
Ansems 2021
    1. Ansems K, Grundeis F, Dahms K, Mikolajewska A, Thieme V, Piechotta V, et al. Remdesivir to treat people with COVID-19. Cochrane Database of Systematic Reviews 2021, Issue 8. Art. No: CD014962. [DOI: 10.1002/14651858.CD014962] - DOI - PMC - PubMed
Beigel 2020
    1. Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, et al. Remdesivir for the treatment of COVID-19 — final report. New England Journal of Medicine 2020;383:1813-26. [DOI: 10.1056/NEJMoa2007764] - DOI - PMC - PubMed
Buitrago‐Garcia 2020
    1. Buitrago-Garcia D, Egli-Gany D, Counotte MJ, Hossmann S, Imeri H, Ipekci Aziz M, et al. Occurrence and transmission potential of asymptomatic and presymptomatic SARS-CoV-2 infections: a living systematic review and meta-analysis. PLOS Medicine 2020;17(9):e1003346-e1003346. [DOI: 10.1371/journal.pmed.1003346] - DOI - PMC - PubMed
CDC 2020
    1. Centers for Disease Control and Prevention. COVIDView - a weekly surveillance summary of U.S. COVID-19 activity (Key updates for week 43). www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html (accessed 22 March 2021).
Chai 2020
    1. Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, et al. Convalescent plasma or hyperimmune immunoglobulin for people with COVID‐19: a living systematic review. Cochrane Database of Systematic Reviews 2020, Issue 7. Art. No: CD013600. [DOI: 10.1002/14651858.CD013600.pub3] - DOI - PMC - PubMed
Chen 2020
    1. Chen T, Wu D, Chen H, Yan W, Yang D, Chen G, et al. Clinical characteristics of 113 deceased patients with coronavirus disease 2019: retrospective study. BMJ 2020;368:m1091. [DOI: 10.1136/bmj.m1091] - DOI - PMC - PubMed
Cochrane LSR
    1. Guidance for the production and publication of Cochrane living systematic reviews: Cochrane Reviews in living mode.. Available from community.cochrane.org/review-production/production-resources/living-sys... (accessed 22 March 2021).
COMET 2020
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COVID‐NMA
    1. Van Nguyen T, Ferrand G, Cohen-Boulakia S, Martinez R, Kapp P, Coquery E, et al for the COVID-NMA consortium. RCT studies on preventive measures and treatments for COVID-19. covid-nma.com (accessed prior to 15 July 2019).
Deeks 2020
    1. Deeks JJ, Higgins JP, Altman DG, editor(s). Chapter 10: Analysing data and undertaking meta-analyses. In: Higgins JP, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, et al, editor(s). Cochrane Handbook for Systematic Reviews of Interventionsversion 6.1 (updated September 2020). Cochrane, 2020. Available from training.cochrane.org/handbook.
DrugBank Online
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EMA 1998
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FDA 2021
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References to other published versions of this review

CRD42021233062
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