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IvermectinNCT04434144

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

An observational study of Ivermectin and Hydroxychloroquine, run by Upazila Health & Family Planning Officer's (UHFPO) Office, Chakoria, Cox's Bazar at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 80 years
Conditions the study is for
Ivermectin, Hydroxychloroquine, COVID19
What is being tested?
Ivermectin + Doxycycline and Hydroxychloroquine + Azithromycin
How many people
116 participants
Where
1 siteBangladesh
Study dates
2 May 2020to 5 Jun 2020
How long will I take part?
5 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site
  • Chakoria Upazilla Health Complex

    Cox’s Bāzār, 4741

Other trials in Bangladesh

About this study

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.

Read the 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.

Being tested
Ivermectin + Doxycycline, Hydroxychloroquine + Azithromycin
Keywords
Ivermectin, Hydroxychloroquine, COVID19, Bangladesh, SARS-CoV-2
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ivermectin + DoxycyclineDrug

    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 + AzithromycinDrug

    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.

Study groups in NCT04434144
Study groupRoleWhat they receive
Group A:Ivermectin 200µgm/kg single dose + Doxycycline 100mg BID for 10days
Receives: Drug: Ivermectin + Doxycycline
Group BHydroxychloroquine 400mg first day then 200mg BID for 9days + Azithromycin 500mg daily for 5Days.
Receives: Drug: Hydroxychloroquine + Azithromycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with "treatment success" determine by a negative RT PCR for COVID19.

    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.

    Measured: 02/05/2020 to 05/06/2020

  2. Number of participants with "adverse effects" determined by the existence of the pharmacological side effects of the particular drug during treatment.

    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.

    Measured: 02/05/2020 to 05/06/2020

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start2 May 2020
  3. Primary completion5 Jun 2020
  4. Study completion5 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
116 participants (actual)
Target duration
5 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT04434144
Sponsor's protocol ID
10000918
Status last verified
Jun 2020
First submitted
9 Jun 2020
Last updated
16 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32283237
  • 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.

    PubMed 32196083
  • 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.

    PubMed 32150618
  • 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.

    PubMed 30266338
  • 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.

    PubMed 32251768

Questions about this trial

What is this clinical trial studying?

An observational study of Ivermectin and Hydroxychloroquine, run by Upazila Health & Family Planning Officer's (UHFPO) Office, Chakoria, Cox's Bazar at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with "treatment success" determine by a negative RT PCR for COVID19. (time frame: 02/05/2020 to 05/06/2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04434144, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.

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