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Randomized Controlled Trial
. 2022 Sep:122:733-740.
doi: 10.1016/j.ijid.2022.07.003. Epub 2022 Jul 8.

The effect of ivermectin on the viral load and culture viability in early treatment of nonhospitalized patients with mild COVID-19 - a double-blind, randomized placebo-controlled trial

Asaf Biber  1 , Geva Harmelin  2 , Dana Lev  1 , Li Ram  2 , Amit Shaham  2 , Ital Nemet  3 , Limor Kliker  3 , Oran Erster  3 , Michal Mandelboim  4 , Eli Schwartz  5
Affiliations
Randomized Controlled Trial

The effect of ivermectin on the viral load and culture viability in early treatment of nonhospitalized patients with mild COVID-19 - a double-blind, randomized placebo-controlled trial

Asaf Biber et al. Int J Infect Dis. 2022 Sep.

Abstract

Objectives: Ivermectin, an antiparasitic agent, also has antiviral properties. In this study, we aimed to assess whether ivermectin has anti-SARS-CoV-2 activity.

Methods: In this double-blinded trial, we compared patients receiving ivermectin for 3 days versus placebo in nonhospitalized adult patients with COVID-19. A reverse transcriptase-polymerase chain reaction from a nasopharyngeal swab was obtained at recruitment and every 2 days for at least 6 days. The primary endpoint was a reduction of viral load on the sixth day as reflected by cycle threshold level >30 (noninfectious level). The primary outcome was supported by the determination of viral-culture viability.

Results: Of 867 patients screened, 89 were ultimately evaluated per-protocol (47 ivermectin and 42 placeboes). On day 6, the odds ratio (OR) was 2.62 (95% confidence interval [CI]: 1.09-6.31) in the ivermectin arm, reaching the endpoint. In a multivariable logistic regression model, the odds of a negative test on day 6 were 2.28 times higher in the ivermectin group but reached significance only on day 8 (OR 3.70; 95% CI: 1.19-11.49, P = 0.02). Culture viability on days 2 to 6 was positive in 13.0% (3/23) of ivermectin samples versus 48.2% (14/29) in the placebo group (P = 0.008).

Conclusion: There were lower viral loads and less viable cultures in the ivermectin group, which shows its anti-SARS-CoV-2 activity. It could reduce transmission in these patients and encourage further studies with this drug.

Keywords: COVID-19; Infectivity duration; Ivermectin; SARS-CoV-2; Viral cultures.

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Figures

Figure 1
Fig. 1
Enrollment and patient flow. Ct = cycle threshold; RT-PCR = reverse transcription-polymerase chain reaction.
Figure 2
Fig. 2
Changes of cycle threshold (Ct) values from base lines during the first 10 days. CI = confidence interval; Ct = cycle threshold.
Figure 3
Fig. 3
Kaplan-Meier curve for time to negative (Ct<30) results for symptoms onset (calculation is done for symptomatic patients, N=69).
See this image and copyright information in PMC

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