COVID19 Clinical Trial
Official title:
A Comparative Observational Study on Ivermectin and Hydroxychloroquine on the COVID19 Patients in Bangladesh
NCT number | NCT04434144 |
Other study ID # | 10000918 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2, 2020 |
Est. completion date | June 5, 2020 |
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.
Status | Completed |
Enrollment | 116 |
Est. completion date | June 5, 2020 |
Est. primary completion date | June 5, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Bangladesh | Chakoria Upazilla Health Complex | Cox's Bazar |
Lead Sponsor | Collaborator |
---|---|
Upazila Health & Family Planning Officer's (UHFPO) Office, Chakoria, Cox's Bazar |
Bangladesh,
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 Apr 3;178:104787. doi: 10.1016/j.antiviral.2020.104787. [Epub ahead of print] — View Citation
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. — View Citation
Patrì 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. — View Citation
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 Mar 9. pii: ciaa237. doi: 10.1093/cid/ciaa237. [Epub ahead of print] — View Citation
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 Mar 20. pii: dkaa114. doi: 10.1093/jac/dkaa114. [Epub ahead of print] — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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