COVID-19 Clinical Trial
Official title:
Randomized Study to Evaluate the Safety and Antiviral Efficacy of Hydroxychloroquine in Patients With Newly Diagnosed COVID-19 Compared to Standard of Care Treatment
This study will assess the efficacy of hydroxychloroquine in reducing the severity of symptoms in patients with COVID-19
Hydroxychloroquine has primarily been raised as a potential treatment of SARS-Cov-2 based on
in vitro antiviral activity. A draft paper was released recently in March by Didier Raoult
from Aix-Marseille University in France on a preliminary trial of 36 COVID-19 patients. In
this trial, 6 patients were asymptomatic, 22 had upper respiratory symptoms, and 8 had lower
respiratory symptoms. Between early and mid-March, they treated 20 of these patients with 600
mg of hydroxychloroquine daily in a hospital setting. Some patient also received the
antibiotic azithromycin. 16 patients served as the controls. They observed a significant
reduction in viral load in patients with hydroxychloroquine. After 6 days, 70% of the treated
patients were considered cured (no virus detected in their samples) compared to 12.5% of
controls. All 6 patients who received both hydroxychloroquine and azithromycin were negative
for the virus after 6 days. This was an unblinded, non-randomized trial.
Vitamin C has multiple in-vivo effects on immune modulation that may, in sum, limit the
development of the cytokine excess associated with critical illness. It is currently being
studied in a clinical trial as a treatment for severe SARS-CoV-2 pneumonia in China and
recommended as a supplement in standard treatment of COVID-19.
There are no medications currently approved for treatment of COVID-19. Hydroxychloroquine is
a known drug with low toxicity that may reduce progression of respiratory symptoms and
resulting hospitalizations. This randomized control study will assess its potential as an
off-label treatment in reducing the rates of hospitalization and subsequent mechanical
ventilation from COVID-19 infection compared to standard of care treatment with Vitamin C. A
randomized control trial with placebo is impractical due to the increasing availability of
this medication to the public.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT06065033 -
Exercise Interventions in Post-acute Sequelae of Covid-19
|
N/A | |
| Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
| Completed |
NCT05047601 -
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04481633 -
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
|
N/A | |
| Recruiting |
NCT05323760 -
Functional Capacity in Patients Post Mild COVID-19
|
N/A | |
| Completed |
NCT04612972 -
Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru
|
Phase 3 | |
| Completed |
NCT04537949 -
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05494424 -
Cognitive Rehabilitation in Post-COVID-19 Condition
|
N/A | |
| Active, not recruiting |
NCT06039449 -
A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
|
Phase 3 | |
| Enrolling by invitation |
NCT05589376 -
You and Me Healthy
|
||
| Completed |
NCT05158816 -
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
|
||
| Recruiting |
NCT04341506 -
Non-contact ECG Sensor System for COVID19
|
||
| Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
| Completed |
NCT04512079 -
FREEDOM COVID-19 Anticoagulation Strategy
|
Phase 4 | |
| Completed |
NCT05975060 -
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT05542862 -
Booster Study of SpikoGen COVID-19 Vaccine
|
Phase 3 | |
| Withdrawn |
NCT05621967 -
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
|
N/A | |
| Terminated |
NCT05487040 -
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
|
Phase 1 | |
| Terminated |
NCT04498273 -
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
|
Phase 3 | |
| Active, not recruiting |
NCT06033560 -
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
|