A Preventive Clinical trial against COVID-19 in Healthy Individuals
- Registration Number
- CTRI/2021/05/033834
- Lead Sponsor
- Biosimilia Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2671
1.A written signed and dated informed consent from subjects and/or legally acceptable representative.
2.Either gender of age between 18 and 65 years (both inclusive)
3.Subject not tested positive for SARSCoV2 virus infection (Individuals not detected with COVID 19 antibodies (Both IgG and IgM) at screening and negative with RT-PCR test as well)
4.Able to comply with study procedures based on the assessment of the Investigator.
5.Asymptomatic subjects (no symptoms of fever, cough, breathlessness in the previous 7 days).
6.Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
7.Healthy adults or adults with pre-existing medical conditions who are in stable condition.
A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
8.Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for >= 12 consecutive months prior to Screening without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the investigator to confirm postmenopausal status.
9.Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:
a. Has a negative pregnancy test at Screening and on the day of randomization (Day 1).
b. Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior randomization (Day 1).
c. Has agreed to continue adequate contraception through 3 months following the last dose.
d. Adequate female contraception is defined as consistent and correct use of a Food and Drug Administration (FDA) approved contraceptive method in accordance with the product label. For example:
e. Barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide
f. Intrauterine device
g. Prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or IM route
h. Sterilization of a female participantâ??s monogamous male partner prior to entry into the study
Note: Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
i. Is not currently breast feeding.
Approximately 3000 heathy participants will be enrolled in two parts; first part will have a set of 200 subjects in phase 2 and the second part will be a continuation of the study for completion of total 3000 subjects in phase 3 (200 in Phase 2+ 2800 in Phase 3). All consenting adults, irrespective of gender and who have not been tested positive for SARS- CoV2 virus infection may be enrolled in the study, considering the specifications of the inclusion and exclusion criteria.
Those who are tested positive for SARS-CoV2 virus infections before enrollment shall not be subjects in this study. Any subject in the study, tested positive for SARS-CoV2 virus infection within 7 days of enrolment in the study, shall cease to be considered as a subject of the study. However, a person developing flu and cold like symptoms will continue to participate in the study if not tested positive for COVID-19.
Eligibility of subject for inclusion in the study will be as per the Inclusion and Exclusion Criteria mentioned in Section 9.2.1 and Section 9.2.2. Demographic characteristics, complete medical and surgical history, vital signs, physical examination.
Inclusion criteria:
1.A written signed and dated data sharing informed consent from subjects and/or legally acceptable representative.
2.Either gender of age between 18 and 65 years (both inclusive)
3.Subject not tested positive for SARSCoV2 virus infection (Individuals not detected with COVID 19 antibodies (Both IgG and IgM) at screening and negative with RT-PCR test as well)
4.Able to comply with study procedures based on the assessment of the Investigator.
5.Asymptomatic subjects (no symptoms of fever, cough, breathlessness in the previous 7 days).
6.Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
7.Healthy adults or adults with pre-existing medical conditions who are in stable condition.
A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
8.Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for >= 12 consecutive months prior to Screening without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the investigator to confirm postmenopausal status.
9.Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:
• Has a negative pregnancy test at Screening and on the day of randomization (Day 1).
• Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior randomization (Day 1).
• Has agreed to continue adequate contraception through 3 months following the last dose.
• Adequate female contraception is defined as consistent and correct use of a Food and Drug Administration (FDA) approved contraceptive method in accordance with the product label. For example:
• Barrier method (such as con
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method