Covid19
Conditions
Brief 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.
Interventions
Hydroxychloroquine tablets 400mg given orally 12 hourly on day 1 and 200mg 12 hourly on day 2 to 5
Sponsors
Makerere University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a confirmed positive Polymerase chain reaction(PCR) test for SARS COV-2 * Adults of ≥ 18 years * Evidence of a personally signed and dated informed consent document indicating that the participant(or their legal representative) has been informed of all pertinent aspects of the study
Exclusion criteria
* Patients with contraindication to the use of hydroxychloroquine e.g. known allergy to hydroxychloroquine * Patients enrolled in another interventional study which may interfere with study results * Patients on medication that are known to have clinically significant interactions with the study drug e.g. digoxin, piperaquine, lumefantrine. * Patients presenting with severe/critically ill COVID-19 (World Health Organization Ordinal scale for clinical improvement score of 5 or more) * Patients with a fever( temperature ≥ 37.5 degrees centigrade) and a positive rapid diagnostic test (RDT) result for malaria * Patients with corrected QT interval (QTc) prolongation of \> 450ms for males and \>470ms for females * Pregnant or breastfeeding women * Patients on chronic hydroxychloroquine use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SARS COV-2 viral clearance | From randomization to day 6 | Attaining a negative PCR- test result i.e. 100% viral clearance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical and laboratory adverse events | From randomization to day 6 | Grade 3 or 4 adverse events |
| Time to symptom clearance | Randomization to day 10 | Time from randomization to symptom clearance |
| Pharmacokinetic-pharmacodynamic model demonstrating drug concentration | Randomization to day 8 | Exposure-outcome relationship of hydroxychloroquine |
| Sero-reversion to negative antibody test | From randomization to day 90 | Antibody sero-reversion |
Countries
Uganda
Outcome results
None listed