Trial to study the effect of Curvic® in vaccinated population for COVID-19

Not Applicable

Completed

• Conditions: Vaccinated for COVID-19; Infections and Infestations; COVID-19 (SARS-CoV-2 infection)

• Registration Number: ISRCTN26285740
• Lead Sponsor: Shreepad Shree Vallabh SSV Phytopharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-02-28
• Study Start: 2022-04-19
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Adult male or female human volunteer of age 18-65 years (inclusive)
2. Eligible for vaccination for COVID-19
3. Willing and able to provide written, signed and dated informed consent
4. Had no medical history or evidence of COVID-2019
5. Had no acute infections and/or respiratory diseases within 14 days before enrollment.
6. Had no evidence of vaccine-induced reactions or complications after receiving immunobiological products in the past medical history.
7. Willing to give consent to use effective contraception methods during the study
8. Have a negative urine pregnancy test at the screening visit (for child-bearing aged women)
9. Have negative human immunodeficiency virus (HIV 1 & 2), syphilis, hepatitis B and C test results

Exclusion Criteria

1. Aged <18 years and >65 years
2. Any vaccination/immunization within 30 days before the enrollment
3. Any treatment with steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products within 30 days before the enrollment
4. Any treatment with immunosuppressive therapy within 3 months before the enrollment
5. Any drug allergy (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, serum disease), hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study drug components, acute exacerbation of allergic diseases on enrollment day
6. Any neoplasms in the past medical history
7. Donated blood or plasma within 3 months before the enrollment
8. Any history or evidence of splenectomy
9. Any immunodeficiency state
10. Any history or evidence of anorexia or protein deficiency of any origin
11. Alcohol or drug addiction in the past medical history
12. Participation in any other interventional clinical trial within 3 months
13. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol
14. Pregnancy or breast-feeding
15. Subjects who are tested positive for Coronavirus disease through RT-PCR SARS CoV-2 Test and positive anti-COVID antibodies within 3 months before the enrollment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Measured by blood test at baseline and 120 days:<br> 1. Absolute lymphocyte count (CD3+, CD4+ and CD8+)<br> 2. Anti-SARS-CoV-2 spike protein (S1 /S2) IgG<br>

Secondary Outcome Measures

Name	Time	Method
Safety of Curvic® with or without vaccine assessed through clinical biochemistry and by symptomatology at baseline and 120 days