NCT04860284

Hydroxychloroquine for Treatment of Non-Severe COVID-19

The Efficacy and Safety of Hydroxychloroquine for the Treatment Of Non-Severe COVID-19 in Adults in Uganda: A Randomized Open Label Phase II Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Makerere University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Currently there are no proven treatments for COVID-19 and current standard therapy is supportive care with oxygen supplementation and treatment of symptoms. Several re-purposed and new drugs have been investigated but none is conclusive for efficacy against COVID-19 .Both Hydroxychloroquine(HCQ) and Chloroquine(CQ) have demonstrated activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and have been investigated in small clinical trials with contradicting reports on their benefits or harm in treatment of COVID-19 .Several authors agree that the use of HCQ for treatment of COVID-19 needs to be assessed in large randomized controlled trials

Detailed description

Currently there are no proven treatments for COVID-19 and current standard therapy is supportive care with oxygen supplementation and treatment of symptoms. Several re-purposed and new drugs have been investigated but none is conclusive for efficacy against COVID-19.These include the antimalarial drugs- chloroquine(CQ) and hydroxychloroquine(HCQ), antivirals such as remdesivir and favipiravir and antiretroviral combination therapies such as lopinavir/ritonavir. Although hydroxychloroquine and chloroquine are readily accessible in Uganda and could be explore for treatment of COVID-19,current data regarding their efficacy and safety is scanty. It is necessary to determine whether HCQ can be useful for treatment of Ugandan patients with COVID-19 for the following reasons : Firstly, the Ugandan population expresses a high level of variability with a younger population with more than 50% under the age of 15 years. Secondly, the population with co-morbid conditions like diabetes mellitus ,hypertension and cardiovascular disease is significantly lower compared to higher income countries. Preliminary data from the first 52 COVID-19 patients in Uganda treated with HCQ demonstrated faster symptom resolution although this did not reach statistical significance. Lastly, HCQ has not been tested in mild-moderate disease where hospitalization is not necessary and we therefore do not know whether it can lead to faster viral clearance, slow disease progression and reduce time to symptom clearance. Our main aim will be to determine if hydroxychloroquine can lead to faster viral clearance.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine tablets	Hydroxychloroquine tablets 400mg given orally 12 hourly on day 1 and 200mg 12 hourly on day 2 to 5

Timeline

• Start date: 2020-09-18
• Primary completion: 2021-02-09
• Completion: 2021-12-01
• First posted: 2021-04-26
• Last updated: 2021-04-26

Locations

1 site across 1 country: Uganda