Table 3.
Table listing ongoing clinical studies investigating the efficacy of HCQ in therapeutic and prophylactic settings with an emphasis on cardiovascular concerns.
| Trail Identifier | Study Title | Study Type/Design | Study Phase | Volunteers (Active) | Interventions/Drug(s) | Active Comparator | Primary Outcome | Location | Study Sponsor |
|---|---|---|---|---|---|---|---|---|---|
| NCT04371926 | Prophylactic Benefit of HCQ in COVID-19 Cases with Mild to Moderate Symptoms and in Healthcare Workers with High Exposure Risk (PREVENT) | Interventional, Randomized | - | 64 | HCQ, 400 mg (day-1), then 200 mg for next 4 days (b.i.d.) | No-HCQ arm | Prophylactic Benefit of HCQ in patients and healthcare workers | - | Texas Cardiac Arrhythmia Research Foundation |
| NCT04341441 | Will Hydroxychloroquine Impede or Prevent COVID-19 (WHIP COVID-19) | Interventional, Randomized | Phase 3 | 3000 | HCQ, 400 mg (day-1), then 200 mg for a week (b.i.d.) | Placebo | Use of HCQ as a preventive therapy against COVID-19 | United States | Henry Ford Health System |
| NCT04371744 | AI for QT Interval Analysis of ECG From Smartwatches in Patient Receiving Treatment for Covid-19 (QT-Logs) | Observational, Cohort, Prospective | - | 100 | Not Applicable | - | Measurement of QTc using an AI and ECG data via smartwatches, compare to standard 12 leads ECG | Marseille, France | Assistance Publique Hopitaux De Marseille |
| NCT043329 | Outcomes Related to COVID-19 treated with HCQ Among In-patients with Symptomatic Disease (ORCHID) | Interventional, Randomized | Phase 3 | 510 | HCQ, 400 mg (day-1), then 200 mg for next 5 days (b.i.d.) | Placebo | Determine the COVID Ordinal Scale for patients on day 15 | United States | Massachusetts General Hospital |
| NCT04353245 | Study of Biomarkers in the Long-term Impact of Coronavirus Infection in the Cardiorespiratory System (PostCOVID19) | Observational [Registry], Case-Control | - | 130 | Arm treatment (HCQ + AZM) | - | Fibrosis on cardiac resonance and/or decreased functional capacity on ergo-spirometry | São Paulo, SP, Brazil | University of Sao Paulo General Hospital |
| NCT04372082 | Hydroxychloroquine or Diltiazem-Niclosamide for the Treatment of COVID-19 (HYdILIC) | Interventional, Randomized | Phase 3 | 480 | HCQ, 2200 mg (t.i.d.) during 10 days in addition to SOC; While niclosamide 500 mg × 4 at J1 then 500 mg (b.i.d.) + diltiazem 60 mg (t.i.d.) during 10 days | HCQ, Diltiazem & Niclosamide | Composite criteria- death, clinical worsening, and assisted-ventilation | Lille, France | University Hospital, Lille, France |
| NCT04361422 | Isotretinoin in Treatment of COVID-19 (Randomized) | Interventional, Randomized | Phase 3 | 300 | Isotretinoin, 13-cis retinoic acid 0.5 mg/kg/day b.i.d. for 1 month. Sham compa- HCQ 500 mg/12 h & other drugs | Active Comp: HCQ and other drugs+ isotretinoin | Viral clearance and COVID-19 virus load | Tanta city, Egypt | Tanta University, Egypt |
| NCT04374019 | Novel Agents for Treatment of High-risk COVID-19 Positive Patients | Interventional (Clinical Trial), Randomized | Phase 2 | 240 | HCQ 200 mg (t.i.b.) for 14 days. HCQ combination with AZM, Ivermectin, and Camostat Mesilate are also enrolled | - | Proportion of patients experiencing clinical deterioration | Kentucky, United States | Susanne Arnold, University of Kentucky |
| NCT04382625 | Hydroxychloroquine in SARS-CoV-2 (COVID-19) Pneumonia Trial | Interventional, Randomized (Open Label) | Phase 4 | 120 | HCQ 400 mg × 2 (800 mg) then 200 mg, t.i.b. (600 mg/24 h period) starting 8 h after 1st dose, total 14 doses over 5 days | - | Data collection, Change from Baseline Oxygenation on Day 1-5 | Washington SU, USA | Kootenai Health, United States |
| NCT04333355 | Safety in Convalescent Plasma Transfusion to COVID-19 | Interventional, Open label | Phase 1 | 20 | Convalescent Plasma | - | Adverse effects of administration of convalescent plasma | Mexico | Hospital San Jose Tec de Monterrey, Mexico |
| NCT04358068 | Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19 | Interventional, Randomized | Phase 2 | 2000 | HCQ (200 × 2 mg day-1, then 200 mg × 2 for 6 days) + AZM (250 mg × 2 mg- Day 0, then 250 mg once daily for 4 doses (4 days) | Placebo | Proportion of patients’ mortality with COVID-19 | San Diego, United States | National Institute of Allergy and Infectious Diseases (NIAID), USA |
| NCT04373044 | Antiviral Therapy and Baricitinib for the Treatment of Patients with Moderate or Severe COVID-19 | Interventional (Clinical Trial), Open label | Phase 2 | 59 | 1) HCQ, PO t.i.d., 2) lopinavir/ritonavir PO b.i.d., or 3) remdesivir. | - | Proportion of patients requiring invasive mechanical ventilation or dying | United States | University of Southern California, United States |
| NCT04349410 | The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol (FMTVDM) | Interventional, Randomized | Phase 2, Phase 3 | 500 | HCQ, 200 mg po q 8 hrs (600 mg qD) for 10-days, & HCQ regime with other drugs | - | Improvement in FMTVDM Analyzed by nuclear imaging | United States | The Camelot Foundation, USA |
Abbreviations: HCQ, Hydroxychloroquine; CQ, Chloroquine; AZM, Azithromycin; SCO, Standard of care; b.i.d., bis in die (twice a day, for HCQ dose); t.i.d., ter in die (trice per day); QTc, Corrected Q and T wave; AI, Artificial intelligence, PO, Per os (Orally); ECG, electrocardiogram; FMTVDM, Fleming Method for Tissue and Vascular Differentiation and Metabolism.