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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04434144
Recruitment Status : Completed
First Posted : June 16, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Abu Taiub Mohammed Mohiuddin Chowdhury, First Affiliated Hospital Xi'an Jiaotong University

Brief 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.

Condition or disease Intervention/treatment
Ivermectin Hydroxychloroquine COVID19 Drug: Ivermectin + Doxycycline Drug: Hydroxychloroquine + Azithromycin

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 116 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group A:
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.

Group B
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.




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

Criteria

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.

Information from the National Library of Medicine

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


Locations
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Bangladesh
Chakoria Upazilla Health Complex
Cox's Bazar, Bangladesh, 4741
Sponsors and Collaborators
Upazila Health & Family Planning Officer's (UHFPO) Office, Chakoria, Cox's Bazar
Investigators
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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:
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Responsible Party: Abu Taiub Mohammed Mohiuddin Chowdhury, Doctoral Resident, First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT04434144    
Other Study ID Numbers: 10000918
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Abu Taiub Mohammed Mohiuddin Chowdhury, First Affiliated Hospital Xi'an Jiaotong University:
Ivermectin
Hydroxychloroquine
COVID19
Bangladesh
SARS-CoV-2
Additional relevant MeSH terms:
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Azithromycin
Doxycycline
Hydroxychloroquine
Ivermectin
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents