COVID19 Clinical Trial
Official title:
A Comparative Observational Study on Ivermectin and Hydroxychloroquine on the COVID19 Patients in Bangladesh
COVID19 is a worldwide pandemic. Hence SARS-CoV-2 is a novel virus; there is no specific medication against it. Like other countries of the world, Bangladesh is also struggling in the case of treatment of this disease. Besides antiviral drugs other existing drugs like Hydroxychloroquine, Chloroquine, and recently Ivermectin has been used for the treatment of mild to moderate cases of COVID19 disease. Till now Hydroxychloroquine has shown a good effect. Recently anti-parasitic drug Ivermectin was found highly effective in an in-vitro study against SARS-CoV-2. This study is aimed to evaluate the efficacy of Ivermectin and Hydroxychloroquine as a combination therapy with antibiotics (Doxycyclin and Azithromycin) and compare the recovery period of these two drugs applied as core monotherapy.
This study was done from May 2nd to June 5th, 2020. The investigators included 181 patients
who were tested positive for SARS-CoV-2 infection by RT PCR presented and the sample
collected at Chokoria Upazila Health Complex, Cox's Bazar; Bangladesh. The PCR analysis of
the collected sample was done at Cox's Bazar Medical College. Each of the participants was
examined carefully to find out the details of the disease symptoms, history, comorbid
condition, and associated complaints. Patients with severe comorbid conditions like severe
Bronchial asthma, COPD exacerbation, severe ischemic heart disease, uncontrolled diabetes
mellitus, advanced renal and hepatic disease, carcinoma, hospitalized and Immuno-compromised
patients were not included in this study. 42 patients had comorbid conditions (some required
hospitalization) that might affect the recovery time; 14 patients were unwilling to
participate in the study and 9 participants did not show-up (3 from group A and 6 from group
B) for follow up sample collection so these were excluded. Following exclusion 116 patients
were included with mild to moderate degree of illness with normal or near-normal chest
radiograph and Oxygen Saturation more than 95% were included in this study. All the patients
enrolled in the study were treated as an outpatient protocol.
For the study Perouse the participants were divided into two groups as follows:
Group A (n=60): Ivermectin 200µgm/kg single dose + Doxycycline 100mg BID for 10days.
Group B (n=56): Hydroxychloroquine 400mg first day then 200mg BID for 9days + Azithromycin
500mg daily for 5Days.
Besides the above, symptomatic treatment for fever, headache, cough, myalgia, and other
complaints were given accordingly. Participants were advised for self-isolation, proper
nutrition, hydration, and a sanitary environment. Treatment outcomes were evaluated on every
2days starting from the 5th day (Asymptomatic patients) or the 2nd non-symptomatic day from
the first day of the drug intake by PCR study of nasopharyngeal and throat swab in each
group. Regular contacts were maintained to find out the adverse or side effects of the
therapy. Informed consent was obtained in every case.
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