A Comparative Study on Ivermectin and Hydroxychloroquine on the COVID19 Patients in Bangladesh
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|ClinicalTrials.gov Identifier: NCT04434144|
Recruitment Status : Completed
First Posted : June 16, 2020
Last Update Posted : June 16, 2020
|Condition or disease||Intervention/treatment|
|Ivermectin Hydroxychloroquine COVID19||Drug: Ivermectin + Doxycycline Drug: Hydroxychloroquine + Azithromycin|
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.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||116 participants|
|Target Follow-Up Duration:||5 Days|
|Official Title:||A Comparative Observational Study on Ivermectin and Hydroxychloroquine on the COVID19 Patients in Bangladesh|
|Actual Study Start Date :||May 2, 2020|
|Actual Primary Completion Date :||June 5, 2020|
|Actual Study Completion Date :||June 5, 2020|
Ivermectin 200µgm/kg single dose + Doxycycline 100mg BID for 10days
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.
Hydroxychloroquine 400mg first day then 200mg BID for 9days + Azithromycin 500mg daily for 5Days.
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.
- Number of participants with "treatment success" determine by a negative RT PCR for COVID19. [ Time Frame: 02/05/2020 to 05/06/2020 ]Treatment outcomes of the COVID19 positive participants will be evaluated on the 5th day in case of an asymptomatic participant; in case of the symptomatic participant, on the 2nd non-symptomatic day onward from the first day of the drug intake by PCR study of nasopharyngeal and throat swab. In the case of still positive PCR, the swab will be collected from the participants after every 2days until the status is negative. A negative PCR is a count of treatment success in each case. The duration (in days) from the first day of drug intake to the negative PCR is the recovery period. Participants who require hospitalization or decease due to the disease progression during the treatment will count as treatment failure.
- Number of participants with "adverse effects" determined by the existence of the pharmacological side effects of the particular drug during treatment. [ Time Frame: 02/05/2020 to 05/06/2020 ]The adverse effect will define as the symptoms expressed by the participants following the starting of the treatment other than the disease symptoms, those are within the proven/enlisted pharmacological side effects of the particular drug therapy. Adverse effects will be evaluated by communication on phone or during the follow up sample collection by detailed history taking. The degree of symptoms will be noted as continuous/occasional and mild/ moderate/severe.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04434144
|Chakoria Upazilla Health Complex|
|Cox's Bazar, Bangladesh, 4741|
|Study Director:||Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD||First Affiliated Hospital Xi'an Jiaotong University|
|Study Chair:||Mohammad Shahbaz, MBBS, MCPS||Upazila Health & Family Planning Officer's (UHFPO) Office, Chakoria, Cox's Bazar|