Table 3.
Representative Practical Well-designed Clinical Trials of Emerging COVID-19 Therapies
| Trial | Geography (target enrollment) | Sponsor | Therapeutic focus | Control | Study design/characteristics | Inclusion/exclusion criteria | Selected outcomes |
|---|---|---|---|---|---|---|---|
| SOLIDARITY120 | Global | World Health Organization | SoC + remdesivir SoC + CQ/HCQ SoC + LPV/RTV SoC + LPV/RTV + IFN β-1a |
SoC | Phase III, adaptive, open-label RCT | ≥18 y and hospitalized with confirmed COVID-19 | Mortality Hospital length of stay Receipt of ventilation or intensive care |
| Trial of Treatments for COVID-19 in Hospitalized Adults (DisCoVeRy) (ClinicalTrials.gov identifier: NCT04315948) | Europe (3100) | Inserm | SoC + remdesivir SoC + LPV/RTV SoC + IFN β-1a SoC + HCQ |
SoC | Phase III multicenter/country, adaptive, open-label RCT | ≥18 y and hospitalized with confirmed COVID-19 + SpO2 ≤94% or acute respiratory failure | Clinical status at day 15 Hospital length of stay Mortality |
| Randomised Evaluation of COVID-19 therapy (RECOVERY) Trial (International Clinical trials Registry Platform identifier: ISRCTN50189673) | United Kingdom (5000) | University of Oxford | SoC + LPV/RTV SoC + IFN β-1a SoC + HCQ SoC + dexamethasone |
SoC | Phase II/III, adaptive, open-label RCT | ≥18 y and hospitalized with confirmed COVID-19 | Mortality within 28 d of randomization Hospital length of stay Number of patients needing ventilation |
| Hydroxychloroquine Versus Placebo in COVID-19 Patients at Risk for Severe Disease (HYCOVID) (ClinicalTrials.gov identifier: NCT04325893) | France (1300) | University Hospital Angers | HCQ | Placebo | Phase III, multicenter, double-blind RCT | ≥18 y with COVID-19 diagnosed within previous 48 h + ≥75 y or SpO2 ≤94% or FiO2 ≤300 mm Hg Electrocardiogram showing the absence of QT interval prolongation |
Mortality or need for intubation and mechanical ventilation within 14 d of inclusion and initiation of treatment Clinical improvement at 14 and 28 d |
| Adaptive COVID-19 Treatment Trial (ACTT) (ClinicalTrials.gov identifier: NCT04280705) | Global (440) | National Institute of Allergy and Infectious Diseases | Remdesivir | Placebo | Phase III, multicenter, adaptive, double-blind RCT | ≥18 y with COVID-19 diagnosed within previous 72 h + radiographic infiltrates by imaging or SpO2 ≤94% or requiring supplemental oxygen or requiring mechanical ventilation | Percentage of participants reporting each severity rating on an 8-point ordinal scale at day 15 Hospital length of stay 14- and 28-d mortality |
| A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia (COVACTA) (ClinicalTrials.gov identifier: NCT04320615) | Global (330) | Hoffmann-La Roche | Tocilizumab | Placebo | Phase III, multicenter, double-blind RCT | ≥18 y and hospitalized with confirmed COVID-19 + SpO2 ≤93% or PaO2 <300 mm Hg | Clinical status assessed with a 7-point ordinal scale at day 28 Incidence of mechanical ventilation 7, 14, 21, 28, and 60-d mortality |
| Convalescent Plasma as Therapy for Covid-19 Severe SARS-CoV-2 Disease (CONCOVID Study) (ClinicalTrials.gov identifier: NCT04342182) | The Netherlands (426) | Erasmus Medical Center | COVID-19 convalescent plasma | SoC | Phase II/III, randomized single-blind, comparative trial | ≥18 y and hospitalized with confirmed COVID-19, excluding patients with a “no ICU admission” or “no invasive ventilation” restriction | Overall mortality until hospital discharge or 60-d Hospital length of stay |
COVID-19 = coronavirus disease 2019; CQ/HCQ = chloroquine or hydroxychloroquine; FiO2 = fraction of inspired oxygen; ICU = intensive care unit; IFN = interferon; LPV/RTV = lopinavir/ritonavir; PaO2 = partial pressure of oxygen; RCT = randomized controlled trial; SoC = standard of care; SpO2 = peripheral capillary oxygen saturation.