COVID-19 Clinical trials: Quality matters more than quantity

Abstract

Despite the ferment aroused in the scientific community by the COVID-19 outbreak and the over 11,000 papers listed in PubMed, published evidence on safe and effective drugs has not progressed yet at the same speed of the pandemic. However, clinical research is rapidly progressing, as shown by the hundreds of registered clinical trials on candidate drugs for COVID-19. Unfortunately, information on protocols of individual studies differs from registry to registry. Furthermore, study designs, criteria for stratification of patients and choice of outcomes are quite heterogeneous. All this makes data sharing and secondary analysis difficult. At last, small single centre studies and the use of drugs on a compassionate basis should be replaced by highly powered, multi-centre, multi-arm clinical trials, in order to provide the required evidence of safety and efficacy of novel or repurposed candidate drugs. Hopefully, the efforts of clinical researchers in the fight against the SARS Cov-2 will result into the identification of effective treatments. To make this possible, clinical research should be oriented by guidelines for more harmonized high-quality studies and by a united commitment of the scientific community to share personal knowledge and data. Allergists and clinical immunologists should have a leading role in this unprecedent challenge.

Keywords: biologics; infections; inflammation; lung diseases other than asthma and COPD; pharmacology and pharmacogenomics.

Figure 1

Staging of COVID‐19. Clinical features, management, and candidate therapeutic options. Modified from Ref. 40 and 47. Legenda: ABG, arterial blood gas; ARDS, acute respiratory distress syndrome; CAP, community‐acquired pneumonia; CBC, complete blood count; CRP, C‐reactive protein; HFNC, high‐flow nasal cannula; ICU, intensive care unit; LFTs, liver function tests; LMWH, low molecular weight heparins; MOF, multi‐organ failure; MSC, mesenchymal stem cells; NIPPV, noninvasive positive pressure ventilation; PaO2/FiO2, ratio of arterial oxygen partial pressure (PaO2, in mm Hg) to fractional inspired oxygen (FiO2, expressed as a fraction); PCR, polymerase chain reaction; RR, respiratory rate; SatO₂, oxygen saturation