SARS-CoV-2 Clinical Trial
— ZITOfficial title:
The Zambia Ivermectin Trial for the Treatment and Prevention of COVID-19
NCT number | NCT04891250 |
Other study ID # | ZIT |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | October 2021 |
Est. completion date | June 2022 |
Verified date | January 2022 |
Source | Centre for Infectious Disease Research in Zambia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study aims to test whether Ivermectin would decrease mortality and reduces chances of getting infected with corona virus, improve management of clinical symptoms and reduce length of stay in ICU and transition probabilities to ICU (ventilator).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2022 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Individuals diagnosed positive for SARS-CoV-2 by real-time reverse transcription PCR (rRT-PCR with presence of a fever, cough, and/or sore throat. Exclusion Criteria: - Patients will be excluded if they report to be allergic to ivermectin or if there is potential for a drug-drug interaction with ivermectin; - Have chronic illnesses (e.g., ischemic heart disease, heart failure, documented cardiomyopathy, chronic kidney disease, chronic liver disease); - Have received ivermectin in the last 7 days; are pregnant or lactating; - Or have participated in any other clinical trial within the last month. |
Country | Name | City | State |
---|---|---|---|
Zambia | University of Zambia | Lusaka |
Lead Sponsor | Collaborator |
---|---|
Centre for Infectious Disease Research in Zambia | Ministry of Health, Zambia, University of Zambia |
Zambia,
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Annweiler C, Beaudenon M, Gautier J, Simon R, Dubée V, Gonsard J, Parot-Schinkel E; COVIT-TRIAL study group. COvid-19 and high-dose VITamin D supplementation TRIAL in high-risk older patients (COVIT-TRIAL): study protocol for a randomized controlled trial. Trials. 2020 Dec 28;21(1):1031. doi: 10.1186/s13063-020-04928-5. — View Citation
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. — View Citation
Chaccour C, Casellas A, Blanco-Di Matteo A, Pineda I, Fernandez-Montero A, Ruiz-Castillo P, Richardson MA, Rodríguez-Mateos M, Jordán-Iborra C, Brew J, Carmona-Torre F, Giráldez M, Laso E, Gabaldón-Figueira JC, Dobaño C, Moncunill G, Yuste JR, Del Pozo JL, Rabinovich NR, Schöning V, Hammann F, Reina G, Sadaba B, Fernández-Alonso M. The effect of early treatment with ivermectin on viral load, symptoms and humoral response in patients with non-severe COVID-19: A pilot, double-blind, placebo-controlled, randomized clinical trial. EClinicalMedicine. 2021 Feb;32:100720. doi: 10.1016/j.eclinm.2020.100720. Epub 2021 Jan 19. — View Citation
Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honoré S, Colson P, Chabrière E, La Scola B, Rolain JM, Brouqui P, Raoult D. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20. — View Citation
Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Sevestre J, Mailhe M, Doudier B, Aubry C, Amrane S, Seng P, Hocquart M, Eldin C, Finance J, Vieira VE, Tissot-Dupont HT, Honoré S, Stein A, Million M, Colson P, La Scola B, Veit V, Jacquier A, Deharo JC, Drancourt M, Fournier PE, Rolain JM, Brouqui P, Raoult D. Clinical and microbiological effect of a combination of hydroxychloroquine and azithromycin in 80 COVID-19 patients with at least a six-day follow up: A pilot observational study. Travel Med Infect Dis. 2020 Mar - Apr;34:101663. doi: 10.1016/j.tmaid.2020.101663. Epub 2020 Apr 11. — View Citation
Heidary F, Gharebaghi R. Ivermectin: a systematic review from antiviral effects to COVID-19 complementary regimen. J Antibiot (Tokyo). 2020 Sep;73(9):593-602. doi: 10.1038/s41429-020-0336-z. Epub 2020 Jun 12. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All-cause COVID-19 related mortality | All-cause COVID-19 related mortality | within 28 days of enrollment | |
Primary | COVID-19 Infection | the proportion of patients on Ivermectin prophylaxis who test positive for COVID 19 using PCR after initially testing negative at enrolment | Study duration | |
Secondary | Patient cure rate | The percentage of cured patients, defined as symptoms free to be discharged from the hospital and the percentage Changes of WHO's OSCI scale for COVID-19 between baseline and day 14 and between baseline and day 28. The study will will also evaluate the time to cure in both groups by measuring time from admission of the patient to the hospital till discharge. | 14- 28 days | |
Secondary | Participant Infection Rate | determine proportion who will develop severe disease and needing admission in addition to the above outcomes. | 90 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
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