Study to assess efficacy of Ivermectin as prophylaxis of COVID -19

Study to assess the efficacy of Ivermectin as prophylaxis of COVID 19 among health care workers and COVID 19 contacts in Ujjain, India

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/05/025333

Enrollment

2000

Registered

2020-05-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Ivermectin: Ivermectin 12 mg OD, oral, for 2 days in adults and 6 mg OD oral, for 2 days in children. Control Intervention1: Control- No intervention: Control- No intervention

Eligibility

Inclusion criteria

Inclusion criteria: Following are eligible to participate after giving written consent/assent - 1. Healthy health care workers 2. Contact of COVID 19

Exclusion criteria

Exclusion criteria: 1. Un healthy 2. Known allergy to study medication or its components (non-medicinal ingredients) 3. Known HIV infection

Design outcomes

Primary

Measure	Time frame
Effect of Ivermectin as prophylaxis of virus Outcome indicators are : 1. Resolution of sign and symptoms of COVID 19 2. Negative RTPCR done 48 hours after Ivermectin dose OR Change /reduction in CT value as reported in RTPCR for SARS-COV-2 virus assay. Timepoint: Change /reduction in CT value as reported in RTPCR after 48 hours of administration drug.	—

Secondary

Measure	Time frame
Overall safety of the study drug The drug is safe in general. However, safety would be monitored by charting adverse events after administration of the drug for 7 days. This will be part of case report form. Secondary outcome indicators: No adverse event after administration of the drug. Adverse events will be systematically recorded and notified to institutional ethics committee Lab values : CT value of RTPCR as reported in primary outcome. Timepoint: 7 Days	—

Measure

Time frame

Overall safety of the study drug The drug is safe in general. However, safety would be monitored by charting adverse events after administration of the drug for 7 days. This will be part of case report form. Secondary outcome indicators: No adverse event after administration of the drug. Adverse events will be systematically recorded and notified to institutional ethics committee Lab values : CT value of RTPCR as reported in primary outcome. Timepoint: 7 Days

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Countries

India

Contacts

Public ContactDr Ashish Pathak

R D Gardi Medical College

drashish.jpathak@gmail.com9302239899

Outcome results