- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cox's Bazar, Bangladesh, 4741
- Chakoria Upazilla Health Complex
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The total number of patients was 116; male 84 and female 26, age 16 to 80years, mean age 33.94years.
Group A (Ivermectin + Doxycyclin): male 43 (71.67%), female 17 (28.33%), age 35.72 ± 15.1 years. Male 37and, female 32.88 years.
Group B (Hydroxychloroquine + Azithromycin): male 47 (83.93%), female 9(16.07%), age 31.91years. Male 31.35, and female 34.5 years.
Description
Inclusion Criteria:
- COVID19 patients confirmed bt RT PCR at Chokoria Upazila Health Complex, Cox's Bazar; Bangladesh.
- Patients with mild to moderate degree of illness.
- Patients with normal or near-normal chest radiograph
- Patients with oxygen Saturation more than 94% who fit the outpatient treatment protocol.
Exclusion Criteria:
- Patients with severe uncontrolled comorbid conditions. (Bronchial asthma, COPD exacerbation, ischemic heart disease, uncontrolled diabetes mellitus, advanced renal and hepatic disease, carcinoma, hospitalized, Immuno-compromised patients)
- BMI>30
- Contraindication / possible drug interaction with Ivermectin and Hydroxychloroquine.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group A:
Ivermectin 200µgm/kg single dose + Doxycycline 100mg BID for 10days
|
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.
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Group B
Hydroxychloroquine 400mg first day then 200mg BID for 9days + Azithromycin 500mg daily for 5Days.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with "treatment success" determine by a negative RT PCR for COVID19.
Time Frame: 02/05/2020 to 05/06/2020
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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.
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02/05/2020 to 05/06/2020
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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
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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.
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02/05/2020 to 05/06/2020
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Collaborators and Investigators
Investigators
- 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
Publications and helpful links
General Publications
- Yao X, Ye F, Zhang M, Cui C, Huang B, Niu P, Liu X, Zhao L, Dong E, Song C, Zhan S, Lu R, Li H, Tan W, Liu D. In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Clin Infect Dis. 2020 Jul 28;71(15):732-739. doi: 10.1093/cid/ciaa237.
- Zhou D, Dai SM, Tong Q. COVID-19: a recommendation to examine the effect of hydroxychloroquine in preventing infection and progression. J Antimicrob Chemother. 2020 Jul 1;75(7):1667-1670. doi: 10.1093/jac/dkaa114.
- Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.
- Lv C, Liu W, Wang B, Dang R, Qiu L, Ren J, Yan C, Yang Z, Wang X. Ivermectin inhibits DNA polymerase UL42 of pseudorabies virus entrance into the nucleus and proliferation of the virus in vitro and vivo. Antiviral Res. 2018 Nov;159:55-62. doi: 10.1016/j.antiviral.2018.09.010. Epub 2018 Sep 26.
- Patri A, Fabbrocini G. Hydroxychloroquine and ivermectin: A synergistic combination for COVID-19 chemoprophylaxis and treatment? J Am Acad Dermatol. 2020 Jun;82(6):e221. doi: 10.1016/j.jaad.2020.04.017. Epub 2020 Apr 10. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Anti-Bacterial Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Doxycycline
- Azithromycin
- Ivermectin
- Hydroxychloroquine
Other Study ID Numbers
- 10000918
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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