Hydroxychloroquine for the Treatment of Mild COVID-19 Disease (COMIHY)
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|ClinicalTrials.gov Identifier: NCT04340544|
Recruitment Status : Terminated (It appeared to be impossible for the study centres to recruit the targeted number of patients, due to reduced incidence and reduced acceptance to IMP)
First Posted : April 9, 2020
Last Update Posted : November 2, 2020
The current outbreak of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) is a global health emergency with a case fatality rate so far approximately 4% and a growing number of confirmed cases (>57.000) in Germany. There is no data available on the efficacy of antiviral agents for the treatment of COVID-19. In-vitro data show that hydroxychloroquine can inhibit SARS-CoV-2  replication and anecdotal reports from Chinese COVID-19 patients [2, 3] suggest that chloroquine is a good candidate for treatment. No data have been published and reported evidence is based on non-controlled use of hydroxychloroquine.
The aim of this placebo-controlled trial is to assess the effect of hydroxychloroquine on duration of symptoms in mild COVID-19 patients and time of virus shedding as an important tool to reduce the risk of further community transmissions. This data will inform practice for the design of larger trials on clinical efficacy of hydroxychloroquine in the treatment and post- and preexposure prophylaxis of COVID-19 and as a tool for reduction of community transmission.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Hydroxychloroquine Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Hydroxychloroquine for the Treatment of Mild COVID-19 Disease|
|Actual Study Start Date :||April 22, 2020|
|Actual Primary Completion Date :||October 12, 2020|
|Actual Study Completion Date :||October 12, 2020|
Hydroxychloroquine 600mg daily for 7 days
Hydroxychloroquine Sulfate is an anti-malarial and anti-rheumatic drug and seems to be a potential candidate for the treatment of COVID-19 since it is able to block virus infection by increasing the endosomal pH, required for virus/cell fusion, it affects the activation of p38 mitogen-activated protein kinase (MAPK), involved in the replication of HCoV-229E and can interfere with the terminal glycosylation of ACE2, thus inhibiting SARS-CoV-2 infection.
Placebo Comparator: Placebo
Equivalent number of placebo capsules
- Difference in time to resolution of clinical signs and symptoms of mild COVID-19 treated with hydroxychloroquine or placebo as assessed by daily self-assessment [ Time Frame: 28±2 days ]
- Difference between hydroxychloroquine- and placebotreated patients on an ordinal outcome scale until Day 28 (death, admission to intensive care, hospitalization, continuing disease, recovered) [ Time Frame: 28±2 days ]
- All-cause mortality within 28 days [ Time Frame: 28±2 days ]
- Proportion of patients with negative COVID-19 PCR test at day 14 in per protocol population as per throat swab [ Time Frame: 28±2 days ]
- Change in COVID-19 virus load from baseline to day 14 [ Time Frame: 28±2 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04340544
|Institute for Tropical Medicine|
|Tübingen, Germany, 72074|