NCT04891250

Brief Summary

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

February 3, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

May 11, 2021

Last Update Submit

January 19, 2022

Conditions

SARS-CoV-2Ivermectin

Outcome Measures

Primary Outcomes (2)

  • All-cause COVID-19 related mortality

    All-cause COVID-19 related mortality

    within 28 days of enrollment

  • 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 Outcomes (2)

  • Patient cure rate

    14- 28 days

  • Participant Infection Rate

    90 days

Study Arms (2)

Intervention

EXPERIMENTAL

Patients with moderate to severe COVID-19 disease will be randomized to either Ivermectin (Intervention) or Standard of Care (Control arm) in a 1:1 ratio

Drug: Ivermectin

Prophylaxis

EXPERIMENTAL

An additional group of patients will be recruited will be randomized to either Ivermectin as prophylaxis (Intervention) or Standard of Care with no ivermectin (Control arm) in a 1:1 ratio

Other: Prophylaxis

Interventions

IvermectinDRUG

Treatment of SARS Cov-2 patients with Ivermectin

Intervention
ProphylaxisOTHER

Treatment of high risk population with Ivermectin as prophylaxis

Prophylaxis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zambia

Lusaka, 10101, Zambia

Location

Related Publications (8)

  • Annweiler C, Beaudenon M, Gautier J, Simon R, Dubee 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.

    PMID: 33371905BACKGROUND

  • Jovanovic A, Klimek P, Renn O, Schneider R, Oien K, Brown J, DiGennaro M, Liu Y, Pfau V, Jelic M, Rosen T, Caillard B, Chakravarty S, Chhantyal P. Assessing resilience of healthcare infrastructure exposed to COVID-19: emerging risks, resilience indicators, interdependencies and international standards. Environ Syst Decis. 2020;40(2):252-286. doi: 10.1007/s10669-020-09779-8. Epub 2020 Jun 4.

    PMID: 32837821BACKGROUND

  • Chaccour C, Casellas A, Blanco-Di Matteo A, Pineda I, Fernandez-Montero A, Ruiz-Castillo P, Richardson MA, Rodriguez-Mateos M, Jordan-Iborra C, Brew J, Carmona-Torre F, Giraldez M, Laso E, Gabaldon-Figueira JC, Dobano C, Moncunill G, Yuste JR, Del Pozo JL, Rabinovich NR, Schoning V, Hammann F, Reina G, Sadaba B, Fernandez-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.

    PMID: 33495752BACKGROUND

  • 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: 32251768BACKGROUND

  • 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, Honore 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.

    PMID: 32289548BACKGROUND

  • 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.

    PMID: 32533071BACKGROUND

  • Ahmed S, Karim MM, Ross AG, Hossain MS, Clemens JD, Sumiya MK, Phru CS, Rahman M, Zaman K, Somani J, Yasmin R, Hasnat MA, Kabir A, Aziz AB, Khan WA. A five-day course of ivermectin for the treatment of COVID-19 may reduce the duration of illness. Int J Infect Dis. 2021 Feb;103:214-216. doi: 10.1016/j.ijid.2020.11.191. Epub 2020 Dec 2.

    PMID: 33278625BACKGROUND

  • Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honore S, Colson P, Chabriere E, La Scola B, Rolain JM, Brouqui P, Raoult D. RETRACTED: 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.

    PMID: 32205204BACKGROUND

MeSH Terms

Interventions

Ivermectin

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients with moderate to severe COVID-19 disease will be randomized to either Ivermectin (Intervention) or Standard of Care (Control arm) in a 1:1 ratio.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2021

First Posted

May 18, 2021

Study Start

October 1, 2021

Primary Completion

December 1, 2021

Study Completion

June 1, 2022

Last Updated

February 3, 2022

Record last verified: 2022-01

Locations

ZA(1)