Table 2.
Select Treatment and Prophylaxis Trials Targeting Viral Cell Entry
| Drug Name | Mechanism of Action | NCT Number | Title | Study Population | Targeted Enrollment | Study Design | Primary Outcome Measure |
|---|---|---|---|---|---|---|---|
| Treatment Trials | |||||||
| Camostat | Viral entry | NCT04321096 | The Impact of Camostat Mesylate on COVID-19 Infection (CamoCo-19) | Age 18–110 yrs, COVID-19–confirmed hospitalized patients (<48 h) or if hospital-acquired COVID-19 is suspected, <48 h since onset of symptoms | 180 | Randomized, double-blind placebo controlled, phase IIa trial | Time to clinical improvement at 30 days |
| Hydroxychloroquine | Viral entry | NCT04315896 | Hydroxychloroquine Treatment for Severe COVID-19 Pulmonary Infection (HYDRA Trial) | Age 18–80 yrs, COVID-19 confirmed by RT-PCR in any respiratory sample; severe disease defined by pulse O2< 91%, 3% decline from baseline pulse O2, or need for increased supplemental O2, mechanical ventilation, or sepsis | 500 | Randomized, double-blind, placebo controlled | All-cause hospital mortality at 120 days |
| Hydroxychloroquine | Viral entry | NCT04316377 | Norwegian Coronavirus Disease 2019 Study (NO COVID-19) | Age >18 yrs, hospitalized, moderately severe disease (NEWS score ≤6); SARS-CoV-2–positive test | 202 | Randomized, open, single arm | Rate of decline in SARS-CoV viral load at 96 h |
| Prophylaxis Trials | |||||||
| Chloroquine phosphate | Viral entry | NCT04303507 | Chloroquine/Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting (COPCOV) | Age ≥16 yrs; health care worker or front-line participant with patient contact working in a health care facility; inpatient or relative of a patient and likely exposed to COVID-19; agree to not self-medicate with potential antivirals | 40,000 | Randomized, double-blind, placebo controlled | Number of symptomatic COVID-19 infections Severity of symptoms |
| Hydroxychloroquine | Viral entry | NCT04308668 | Post-exposure Prophylaxis/Pre-emptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP) | Age >18 yrs; exposure to a COVID-19 case within 4 days as either a health care worker or household contact; symptomatic COVID-19 case with confirmed diagnosis within 4 days of symptom onset; or symptomatic health care worker with known COVID-19 contact and within 4 days of symptom onset | 3,000 | Randomized, double-blind, placebo controlled | Incidence of COVID-19 disease at 14 days Ordinal Scale of COVID-19 disease severity at 14 days |
| Hydroxychloroquine | Viral entry | NCT04318444 | Hydroxychloroquine Post Exposure Prophylaxis for Coronavirus Disease (COVID-19) | Age >18 yrs; household contact of index case: currently residing in the same household as an individual evaluated at NYP via outpatient, ED, or inpatient services who (1) tests positive for COVID-19, or (2) is defined as suspected case, or PUI, by the treating physician | 1,600 | Randomized, double-blind, placebo controlled | Symptomatic, lab-confirmed COVID-19 |
| Hydroxychloroquine | Viral entry | NCT04318015 | Hydroxychloroquine Chemoprophylaxis in Healthcare Personnel in Contact With COVID-19 Patients (PHYDRA Trial) | Age >18 yrs; health care personnel exposed to patients with COVID-19 respiratory disease (physicians, nurses, chemists, pharmacists, janitors, stretcher-bearer, administrative, and respiratory therapists) | 400 | Randomized, double-blind, placebo controlled | Symptomatic COVID-19 infection rate at 60 days |
For an up-to-date listing of trials, search for “COVID-19” at the ClinicalTrials.gov website.
ED = emergency department; NEWS = National Early Warning Score; NYP = New York Presbyterian; PUI = person under investigation; RT-PCR = reverse transcriptase-polymerase chain reaction; other abbreviations as in Table 1.