A small randomised control trial involving 62 COVID-19 patients found the malaria drug hydroxychloroquine can improve pneumonia and reduce the time to clinical recovery. No serious adverse effects were seen.
A small trial involving 62 COVID-19 patients admitted to the Renmin Hospital of Wuhan University has found that the malaria drug hydroxychloroquine given to patients helps shorten the time to clinical recovery. The trial had a treatment and a control arm of 31 patients each.
The results of the trial were posted on preprint server medRxiv on March 31. Preprints are yet to be peer-reviewed and published in a medical journal.
The researchers from the Renmin Hospital of Wuhan University found that nearly 81% (25 of 31) of patients in the treatment group showed improved pneumonia compared with the control group (55% or 17 of 31 patients). Only four of 62 patients progressed to severe illness and all the four were in the control arm. Two patients had mild adverse reaction (rash and headache) to the drug, while no severe side effects were seen.
Approval by ICMR
Based on the recommendation of the Task Force for coronavirus disease (COVID-19), on March 23, the Indian Council of Medical Research (ICMR) approved the use of hydroxychloroquine as prophylaxis by healthcare workers taking care suspected or confirmed COVID-19 cases and asymptomatic household contacts of confirmed cases.
India is all set to join World Health Organization’s multi-country “Solidarity trial” aimed testing four drug combinations including chloroquine to treat COVID-19. On March 29, the Food and Drug Administration issued an emergency use authorisation for hydroxychloroquine and chloroquine for COVID-19 treatment.
Soon after the U.S. President Donald Trump championed for hydroxychloroquine as a treatment for COVID-19, two Nigerians are reported to have over-dosed on the drug. A man in Arizona, U.S., died and his wife was hospitalised after they self-medicated with a home remedy of hydroxychloroquine. A doctor in India died after taking two doses of the drug.
Outcomes of the trial
Patients in the treatment arm received hydroxychloroquine 400 mg per day in addition to standard treatment for five consecutive days, while those in the control group received only the standard treatment. Patients were randomly assigned to either the treatment or control group.
The researchers looked for changes in the time taken for clinical recovery, which was defined as return to normal body temperature and cough relief for more than three days. They also looked for radiological changes using chest CT.
While 22 of 31 patients in the treatment group and 17 of 31 patients in the control group had a fever when the trial began, the time taken achieve normal body temperature was “significantly shorter” for the treatment group, the preprint says. Also, cough remission was “significantly reduced” in the treatment group.
Chest CT showed pneumonia condition improved in 25 of 31 patients (nearly 81%) in the treatment group compared with 17 of 31 (55%) patients in the control group. Of the 81% who showed improved pneumonia in the treatment group, 61% had “significant pneumonia absorption”.
“Despite our small number of cases, the potential of HCQ in the treatment of COVID-19 has been partially confirmed,” they write.