NCT04434144

A Comparative Study on Ivermectin and Hydroxychloroquine on the COVID19 Patients in Bangladesh

A Comparative Observational Study on Ivermectin and Hydroxychloroquine on the COVID19 Patients in Bangladesh

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 116 (actual)
• Sponsor: Upazila Health & Family Planning Officer's (UHFPO) Office, Chakoria, Cox's Bazar · Other Government
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ivermectin
• Hydroxychloroquine
• COVID19

Interventions

Type	Name	Description
DRUG	Ivermectin + Doxycycline	SARS-CoV-2 infection was confirmed by RT PCR in every case. For group A, Ivermectin 200mcg/kg single dose and Doxycycline 100mg BID for 10 days were given. For group B, Hydroxychloroquine 200mg BID for 10 days and Azithromycin 500mg single daily dose for 5days was given. Before advising the contraindications and possible adverse effect and drug interactions were kept in consideration. Incase of asymptomatic patients, repeat sample collection (nasopharyngeal and throat swab) for PCR was done on 5th day. For the symptomatic patients, this duration was on the 3rd nonsymptomatic day from the first day of drug intake. In the case of positive PCR, the test was repeated after 2days and onward.
DRUG	Hydroxychloroquine + Azithromycin	SARS-CoV-2 infection was confirmed by RT PCR in every case. For group B, Hydroxychloroquine 400mg first day then 200mg BID + Azithromycin 500mg BID for 5 days were given. For group B, Hydroxychloroquine 200mg BID for 10 days and Azithromycin 500mg single daily dose for 5days was given. Before advising the contraindications and possible adverse effect and drug interactions were kept in consideration. Incase of asymptomatic patients, repeat sample collection (nasopharyngeal and throat swab) for PCR was done on 5th day. For the symptomatic patients, this duration was on the 2nd nonsymptomatic day from the first day of drug intake. In the case of positive PCR, the test was repeated after 2days and onward.

Timeline

• Start date: 2020-05-02
• Primary completion: 2020-06-05
• Completion: 2020-06-05
• First posted: 2020-06-16
• Last updated: 2020-06-16

Locations

1 site across 1 country: Bangladesh

Regulatory

• FDA-regulated drug study