Table 3.
Select Treatment Trials Targeting Viral Replication
| Drug Name | Mechanism of Action | NCT Number | Title | Study Population | Targeted Enrollment | Study Design | Primary Outcome Measure |
|---|---|---|---|---|---|---|---|
| Umifenovir | Antiretroviral | NCT04260594 | Clinical Study of Arbidol Hydrochloride Tablets in the Treatment of Pneumonia Caused by Novel Coronavirus | Age ≥18 yrs; subjects with pneumonia diagnosed as 2019-nCoV infection; detection of 2019-nCoV nucleic acid–positive by RT-PCR in respiratory tract or blood samples; virus gene sequence of respiratory tract or blood samples is highly homologous to the known 2019-nCoV | 380 | Randomized, single-arm, open-label umifenovir | Negative viral conversion rate at 7 days |
| ASC09 + ritonavir; lopinavir + ritonavir | Antiretroviral | NCT04261907 | Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Novel Coronavirus Infection | Age between 18 to 75 yrs; lab (RT-PCR) and clinically confirmed case of 2019-nCoV pneumonia; hospitalized with a new onset respiratory illness (≤7 days since illness onset) | 160 | Randomized, open-label ASC09/ritonavir or lopinavir/ritonavir | The incidence of adverse outcomes, defined by at least 1 of the following: pulse O2 ≤93% without O2 supplementation, PaO2-to-FiO2 ratio ≤300 or RR ≥30 breaths/min assessed at 14 days |
| Darunavir + cobicistat | Antiretroviral | NCT04252274 | Efficacy and Safety of Darunavir and Cobicistat for Treatment of COVID-19 (DC-COVID-19) | Pneumonia caused by 2019-nCoV | 30 | Randomized, open-label, single-arm | The viral clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 |
| Lopinavir + ritonavir; umifenovir | Antiretroviral | NCT04252885 | The Efficacy of Lopinavir Plus Ritonavir and Arbidol Against Novel Coronavirus Infection (ELACOI) | Age 18–80 yrs; confirmation of SARS-CoV-2 infection by RT-PCR with normal kidney and liver function | 125 | Randomized, open-label (1:1:1) to lopinavir + ritonavir; or umifenovir; or standard care | The rate of viral inhibition, as determined by RT-PCR at days 2, 4, 7, 10, 14, and 21 |
| Lopinavir + ritonavir | Antiretroviral | NCT04330690 | Treatments for COVID-19: Canadian Arm of the SOLIDARITY Trial (CATCO) | Age >6 months with confirmed SARS-CoV-2 by RT-PCR, admitted to hospital | 440 | Randomized, open-label (1:1) of lopinavir + ritonavir or standard care | Efficacy of intervention at 29 days as determined by 10-point ordinal scale of clinical status |
| Remdesivir | Antiretroviral | NCT04280705 | Adaptive COVID-19 Treatment Trial (ACTT) | Age 18–99 yrs, PCR-confirmed novel coronavirus infection by lab assay; illness as defined by abnormal radiographic imaging, clinical assessment, and pulse O2 ≤94%, requiring O2, or requiring mechanical ventilation | 572 | Adaptive, randomized, double-blind placebo controlled | Time to recovery at day 29 |
| Remdesivir | Antiretroviral | NCT04292899 | Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734) in Participants With Severe Coronavirus Disease (COVID-19) | Age ≥18 yrs; confirmation of SARS-CoV-2 infection by RT-PCR ≤4 days before randomization; current hospitalization with pulse O2≤ 94% | 6,000 | Randomized, open-label study of remdesivir 5 days; or remdesivir 10 days | Odds of clinical improvement on a 7-point ordinal scale by day 11 |
| Remdesivir | Antiretroviral | NCT04292730 | Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment | Age ≥18 yrs; confirmation of SARS-CoV-2 infection by RT-PCR ≤4 days before randomization; current hospitalization with fever, pulse O2 >94%, radiographic evidence of pulmonary infiltrates | 1,600 | Randomized, open-label study of remdesivir 5 days; or remdesivir 10 days; or standard of care | Odds of clinical improvement on a 7-point ordinal scale by day 11 |
For an up-to-date listing of trials, search for “COVID-19” at the ClinicalTrials.gov website.