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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Active Comparator | Participants will receive 400mg of hydroxychloroquine tablets 12-hourly on day 1 and 200mg 12-hourly on day 2 to day 5 in addition to standard of care treatment for COVID-19 |
|
| Control arm | No Intervention | Participants will receive only standard of care treatment for COVID-19 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine tablets | Drug | Hydroxychloroquine tablets 400mg given orally 12 hourly on day 1 and 200mg 12 hourly on day 2 to 5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| SARS COV-2 viral clearance | Attaining a negative PCR- test result i.e. 100% viral clearance | From randomization to day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical and laboratory adverse events | Grade 3 or 4 adverse events | From randomization to day 6 |
| Time to symptom clearance | Time from randomization to symptom clearance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pauline Byakika-Kibwika, PhD | Makerere University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Namboole COVID-19 treatment unit | Kampala | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34872511 | Derived | Byakika-Kibwika P, Sekaggya-Wiltshire C, Semakula JR, Nakibuuka J, Musaazi J, Kayima J, Sendagire C, Meya D, Kirenga B, Nanzigu S, Kwizera A, Nakwagala F, Kisuule I, Wayengera M, Mwebesa HG, Kamya MR, Bazeyo W. Safety and efficacy of hydroxychloroquine for treatment of non-severe COVID-19 among adults in Uganda: a randomized open label phase II clinical trial. BMC Infect Dis. 2021 Dec 6;21(1):1218. doi: 10.1186/s12879-021-06897-9. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Randomization to day 10 |
| Pharmacokinetic-pharmacodynamic model demonstrating drug concentration | Exposure-outcome relationship of hydroxychloroquine | Randomization to day 8 |
| Sero-reversion to negative antibody test | Antibody sero-reversion | From randomization to day 90 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |