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

NCT04434144 | Completed DMC FDA Drug

• 1 other identifier: 10000918
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Ivermectin; Hydroxychloroquine; COVID19

Keywords

Ivermectin; Hydroxychloroquine; COVID19; Bangladesh; SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• 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.

  02/05/2020 to 05/06/2020

• 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.

  02/05/2020 to 05/06/2020

Study Arms (2)

Group A:

Ivermectin 200µgm/kg single dose + Doxycycline 100mg BID for 10days

Drug: Ivermectin + Doxycycline

Group B

Hydroxychloroquine 400mg first day then 200mg BID for 9days + Azithromycin 500mg daily for 5Days.

Drug: Hydroxychloroquine + Azithromycin

Interventions

Ivermectin + Doxycycline DRUG

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 A:

Hydroxychloroquine + Azithromycin DRUG

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.

Group B

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Upazila Health & Family Planning Officer's (UHFPO) Office, Chakoria, Cox's Bazar: lead

Study Sites (1)

Chakoria Upazilla Health Complex

Cox’s Bāzār, 4741, Bangladesh

Location

Related Publications (5)

• 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.

  PMID: 32283237 BACKGROUND

• 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.

  PMID: 32196083 BACKGROUND

• 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.

  PMID: 32150618 BACKGROUND

• 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.

  PMID: 30266338 BACKGROUND

• 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.

  PMID: 32251768 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Ivermectin; Doxycycline; Hydroxychloroquine; Azithromycin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin

Study Officials

• Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY DIRECTOR

• Mohammad Shahbaz, MBBS, MCPS

  Upazila Health & Family Planning Officer's (UHFPO) Office, Chakoria, Cox's Bazar

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Resident

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 16, 2020
• Study Start: May 2, 2020
• Primary Completion: June 5, 2020
• Study Completion: June 5, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

BA (1)