Clinical trial NCT04392713: Efficacy of Ivermectin in COVID-19
Official title: Efficacy of Ivermectin in COVID-19 : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID
Lead sponsor: Combined Military Hospital, Pakistan
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Negative PCR
timeFrame: 144 hours
Secondary outcomes:
measure: Need for mechanical ventilation
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Combined Military Hospital Lahore
state: Punjab
Study officials:
affiliation: Combined military hospital lahore
name: Karamat Hu Bukhari, FCPS MED
role: STUDY_DIRECTOR
References:
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.
citation: Simsek Yavuz S, Unal S. Antiviral treatment of COVID-19. Turk J Med Sci. 2020 Apr 21;50(SI-1):611-619. doi: 10.3906/sag-2004-145.