Clinical Trials Logo
  1. Home
  2. Coronavirus
  3. NCT04325893

Hydroxychloroquine Versus Placebo in COVID-19 Patients at Risk for Severe Disease — HYCOVID  

Coronavirus Clinical Trial

Official title:
Hydroxychloroquine Versus Placebo in Patients Presenting COVID-19 Infection and at Risk of Secondary Complication: a Prospective, Multicentre, Randomised, Double-blind Study

Clinical Trial Summary

A new human coronavirus responsible for pneumonia, SARS-CoV-2, emerged in China in December 2019 and has spread rapidly. COVID-19, the disease caused by this virus, has a very polymorphous clinical presentation, which ranges from upper respiratory tract infections to acute respiratory distress syndrome. It may appear serious straightaway or may evolve in two stages, with a worsening 7 to 10 days after the first clinical signs, potentially linked to a cytokine storm and accompanied by a high risk of thrombosis. The global mortality rate of COVID-19 is between 3% and 4%, with severe forms being more frequent among older patients. Management is symptomatic as no antiviral treatment has demonstrated any clinical benefit in this condition. Hydroxychloroquine is a derivative of chloroquine commonly used in some autoimmune diseases, such as systemic lupus erythematosus. It is active in vitro in cellular models of infection by many viruses such as HIV, hepatitis C or SARS-CoV. However, its interest in viral infections in humans has not been demonstrated.

Very recently, a preliminary uncontrolled study evaluated the effect of hydroxychloroquine on viral shedding in subjects with COVID-19. Among 20 patients treated with hydroxychloroquine at a dose of 600 mg per day, the percentage of patients with detectable SARS-CoV-2 RNA in the nasopharynx decreased from 100% at inclusion (start of treatment) to 43% six days later. In comparison, 15 of 16 untreated patients had a positive RT-PCR six days after inclusion. Furthermore, hydroxychloroquine has immunomodulating and anti-inflammatory properties, which could theoretically prevent or limit secondary worsening.

The research hypothesis is that treatment with hydroxychloroquine improves prognosis and reduces the risk of death or use for invasive ventilation in patients with COVID-19.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04325893
Study type Interventional
Source University Hospital, Angers
Contact
Status Terminated
Phase Phase 3
Start date April 1, 2020
Completion date June 18, 2020
View Details
See also
  Status Clinical Trial Phase
Completed NCT05065827 - Lung Ultrasound Findings in Patients With COVID-19 in a UK ED
Recruiting NCT05359770 - Association of Inspiratory Muscle Training With HD-tDCS for Assistance to Patients With Long Covid-19 N/A
Completed NCT04515147 - A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19 Phase 2
Not yet recruiting NCT06025812 - Clinical Study of Omicron BA.4/5-Delta Strain Recombinant Novel Coronavirus Protein Vaccine (CHO Cells) N/A
Recruiting NCT05289115 - Protocol for Assistance to Patients With Long Covid-19 Undergoing Treatment With HD-tDCS N/A
Completed NCT04953078 - A Study to Evaluate Safety, Tolerability, and Reactogenicity of an RBD-Fc-based Vaccine to Prevent COVID-19 Phase 1
Completed NCT04779138 - Increasing Vaccine Uptake in Underresourced Public Housing Areas N/A
Not yet recruiting NCT05868239 - Impact of Aerosol Box Use During Cardiopulmonary Arrest: A Multicenter Study N/A
Completed NCT04690413 - NOWDx Test for the Detection of Antibodies to COVID-19 N/A
Completed NCT04818164 - Prone Position Improves End-Expiratory Lung Volumes in COVID-19 Acute Respiratory Distress Syndrome
Terminated NCT04530448 - Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization Phase 4
Completed NCT04572399 - UVA Light Device to Treat COVID-19 N/A
Recruiting NCT04610567 - Treatment of Patients With Mild Coronavirus-19 (COVID-19) Disease With Methotrexate Associated to LDL Like Nanoparticles (Nano-COVID19) Phase 1/Phase 2
Completed NCT04551911 - Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19 Phase 2
Recruiting NCT04772170 - Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies
Recruiting NCT04581954 - Inflammatory Signal Inhibitors for COVID-19 (MATIS) Phase 1/Phase 2
Completed NCT04405934 - COG-UK Project Hospital-Onset COVID-19 Infections Study N/A
Enrolling by invitation NCT04484025 - SPI-1005 Treatment in Moderate COVID-19 Patients Phase 2
Completed NCT05572840 - Wear Your Mask, Wash Your Hands, Don't Get COVID-19 N/A
Withdrawn NCT04838847 - A Study to Evaluate the Immunogenicity and Safety of the SARS-CoV-2 mRNA Vaccine CVnCoV in Elderly Adults Compared to Younger Adults for COVID-19 Phase 3