Efficacy of Ivermectin in COVID-19

COVID Clinical Trial

Official title:

Efficacy of Ivermectin in COVID-19 : A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04392713
• Other study ID #: IVE-COV
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2020
• Est. completion date: July 2020

Study information

• Verified date: May 2020
• Source: Combined Military Hospital, Pakistan
• Contact: Asma Asghar, FCPS MED
• Phone: 00923225141033
• Email: Asghar.asma79[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is a randomized controlled trial to assess the efficacy of Ivermectin in COVID-19. Patient recruited will be assigned to two groups one group will be given ivermectin with standard chloroquine regimen and the other group will be receiving chloroquine only. Out come will be recorded by documenting PCR reports at 48, 96 and 144 hours.

Description:

INTERVENTION It will be a randomized controlled trial which will be done on COVID-19 patients proven by PCR fulfilling the criteria (asymptomatic/mild to moderate severity). They will be divided into two groups after randomization. Group A will be administered Ivermectin single dose of 12grams along with Chloroquine as per existing hospital guidelines and group B will be given Chloroquine alone. Dose of Ivermectin to be repeated at 1 week if PCR stays negative. PCR will be done on alternate days (48, 96 and 144hours) and the duration at which the PCR becomes negative will be compared. Dose of drug subject to change in accordance with patient response or possible side effect.

ELIGIBILITY CRITERIA INCLUSION CRITERIA

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged 15 to 65 years In good general health with no or mild symptoms of Corona virus disease PCR positive for SARS-Cov-2. Ability to take oral medication and be willing to adhere to the drug intake regimen EXCLUSION CRITERIA

An individual who meets any of the following criteria will be excluded from participation in this study:

Severe symptoms likely attributed to Cytokine Release Storm. Malignant diseases, diabetes mellitus, chronic kidney disease and cirrhosis liver with CPT class B or C.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

Inclusion Criteria:

• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Male or female, aged 15 to 65 years

• In good general health with no or mild to moderate symptoms of Corona virus disease

• PCR positive for SARS-Cov-2.

• Ability to take oral medication and be willing to adhere to the drug intake regimen

Exclusion Criteria:

• Severe symptoms likely attributed to Cytokine Release Storm.

• Malignant diseases, diabetes mellitus, chronic kidney disease and cirrhosis liver with CPT class B or C.

Related Conditions & MeSH terms

• COVID

Intervention

Drug:
• Ivermectin 6 MG Oral Tablet (2 tablets)
12 mg single dose of Ivermectin will be given to intervention arm

Locations

Country	Name	City	State
Pakistan	Combined Military Hospital Lahore	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Combined Military Hospital, Pakistan

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

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

Simsek Yavuz S, Ünal S. Antiviral treatment of COVID-19. Turk J Med Sci. 2020 Apr 21;50(SI-1):611-619. doi: 10.3906/sag-2004-145. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative PCR	PCR will be done at 48, 96 and 144 hours	144 hours
Secondary	Need for mechanical ventilation	All patients will be assessed for requirement of mechanical ventilation in both the groups	4 weeks