Ivermectin in COVID

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2020/06/026001
• Date of registration: 21-06-2020
• Prospective Registration: Yes
• Primary sponsor: AIIMS New Delhi
• Public title: Ivermectin in COVID
• Scientific title: Randomised Controlled Trial of Ivermectin in hospitalised patients with COVID19 - RIVET-COV
• Date of first enrolment: 25-06-2020
• Target sample size: 120
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44196
• Study type: Interventional
• Study design: Randomized, Parallel Group, Multiple Arm Trial; Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
• Phase: Phase 2/ Phase 3

Countries of recruitment

India

Contacts

• Name: Anant Mohan
• Affiliation: AIIMS New Delhi

• Name: Anant Mohan
• Affiliation: AIIMS New Delhi

Key inclusion & exclusion criteria

Inclusion criteria: diagnosed COVID19 patients admitted to AIIMS COVID facility

Age > 18 years

Informed consent

Non-severe disease: Non-severe disease (Asymptomatic/ Mild

disease OR moderate): SpO2>=90% on room

air with presence of clinical features of

dyspnea and/or hypoxia, fever, cough and/or

Respiratory Rate more or equal to 24 per

minute
Exclusion criteria: Not giving written informed consent

ALT/AST >5 times the upper limit of normal.

Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30).

Pregnant or breast feeding.

Allergy to any study medication.

Severe co-morbidity as per investigatorâ??s assessment

Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment.

Prolonged QT interval ( >450 ms)

Any other concomitant therapeutic trial

Weight <15 kg



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Intervention(s)

Intervention1: Intervention Arm 1: 12 mg (200 microgram/kg)
Formulation: elixir
Route of administration: oral
Frequency: Only single dose
Intervention2: Intervention Arm 2: 24 mg (400 microgram/kg)
Formulation: elixir
Route of administration: oral
Frequency: Only single dose
Intervention3: Intervention Arm 3: 48 mg (800 microgram/kg)
Formulation: elixir
Route of administration: oral
Frequency: Only single dose
Intervention4: Intervention Arm 4
: 96 mg (1600 microgram/kg)
Formulation: elixir
Route of administration: oral
Frequency: Only single dose
Intervention5: Intervention Arm 5
: 120 mg (2000 microgram/kg)
Formulation: elixir
Route of administration: oral
Frequency: Only single dose
Control Intervention1: Placebo: placebo
Formulation: Elixir of similar taste and consistency
Frequency: only single dose

alongwith
Standard medical care as per treating physician and institution

Primary Outcome(s)

Two co-primary outcomes

1. Frequency of RTPCR negativity at day 5 after drug administration

2. Change in viral load (as determined by RTPCR cycle threshold) at day 5 as compared to baselineTimepoint: Day 5 after drug administration

Secondary Outcome(s)

Qualitative and quantitative PCR for SARS CoV-2 in pharyngeal swab on days 0, 3, 5,

and 7 (while hospitalized) in both armsTimepoint: days 0, 3, 5, and 7 (while hospitalized)

Frequency of clinical worsening in study group as compared to standard careTimepoint: till discharge or death

Clinical status of subject at week 2 (on a 7-point ordinal scale) as follows: Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Death.Timepoint: Week 2

Frequency of serious adverse events in study

group as compared to standard careTimepoint: till death or discharge

Time to clinical resolution in study group as compared to standard careTimepoint: till discharge or death

Secondary ID(s)

NIL

Source(s) of Monetary Support

All India Institute of Medical Sciences New Delhi

Secondary Sponsor(s)

All India Institute of Medical Sciences New Delhi

Ethics review

Status: Approved
Approval date: 02/06/2020
Contact:

Institute Ethics Committee

Status: Approved
Approval date: 10/08/2020
Contact:

Institute Ethics Committee

Status: Approved
Approval date: 06/10/2020
Contact:

Institute Ethics Committee