Trial to study the effect of Curvic® in vaccinated population for COVID-19
| ISRCTN | ISRCTN26285740 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26285740 |
| Secondary identifying numbers | SSV-SF-01/2021 |
- Submission date
- 14/03/2022
- Registration date
- 19/04/2022
- Last edited
- 20/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Vaccination is protective against COVID-19 infections. Based on recent studies by Shreepad Shree Vallabh SSV Phytopharmaceuticals, it has been scientifically proven that Curvic® is effective against all species of coronavirus by blocking the Main Protein (Mpro). The efficacy of Curvic® has been proven in quarantined patients as an immunity booster and also in a randomized double-blind trial for the management of SARS-COV-2 (COVID-19) infection. We plan to conduct the current study to evaluate the role of Curvic® in the COVID-19 vaccinated population.
Who can participate?
Adult male or female volunteers of age 18-65 years (inclusive), who are eligible for vaccination for COVID-19
What does the study involve?
After vaccination, participants will be randomly allocated to receive Curvic® or not. Blood samples will be taken at baseline and 120 days
What are the possible benefits and risks of participating?
The supplement Curvic® may benefit participants who are vaccinated for COVID-19. Curvic®, being a nutraceutical supplement, possesses no risk to the participants consuming it. This has been proven in various clinical trials carried out previously for the formulation.
Where is the study run from?
Sukhkarta Hospital (India)
When is the study starting and how long is it expected to run for?
March 2021 to February 2022
Who is funding the study?
Shreepad Shree Vallabh SSV Phytopharmaceuticals (India)
Who is the main contact?
Dr Yogesh Dound, yogesh_dound@yahoo.com
Contact information
Scientific
201/2, Old Kashmiri Building
R. R. Thakur Marg
Majas Wadi
Jogeshwari (E)
Mumbai
400060
India
 ORCID ID |
0000-0002-7627-2438 |
|---|---|
| Phone | +91 9769057549 |
| yogesh_dound@yahoo.com |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 41348_PIS_v1_09Mar2021.pdf |
| Scientific title | A randomized controlled trial to study the immunogenicity and safety of Curvic® in a vaccinated population for COVID-19 |
| Study acronym | SSV-SF-01/2021 |
| Study objectives | Vaccination is protective against COVID 19 infections. Based on recent studies by Shreepad Shree Vallabh SSV Phytopharmaceuticals, it has been scientifically proven that Curvic® is effective against all species of coronavirus by blocking the Main Protein (Mpro). The efficacy of Curvic® has been proven in quarantined patients as an immunity booster and also in a randomized double-blind trial for the management of SARS-COV-2 (COVID-19) infection. We plan to conduct the current study to evaluate the role of Curvic® in the vaccinated population for COVID 19. |
| Ethics approval(s) | Approved 21/03/2021, Navsanjeevani Hospital Ethics Committee (Nashik, Maharashtra, India; +91 9822574157; navsanjeevaniec@gmail.com), ref: none provided |
| Health condition(s) or problem(s) studied | Vaccinated for COVID-19 |
| Intervention | The study shall include 50 healthy volunteers eligible for vaccination for COVID-19. These volunteers will be screened for Absolute Lymphocyte Count (CD3+, CD4+ and CD8+) and Anti SARS-CoV-2 spike protein (S1 /S2) IgG. Once vaccinated, they will be divided in two groups: Group A: (N=25) Curvic® given to vaccinated population for COVID-19 for 120 days Group B: (N=25) Only vaccinated population for COVID-19 Once vaccinated they will follow the protocol for post vaccination. Based on the type of vaccination, whichever is the due date for 2nd vaccination will be followed by the respective volunteer. After completion of 120 days from first dose of vaccination, the volunteers will be again screened for Absolute Lymphocyte Count (CD3+, CD4+ and CD8+) and Anti SARS-CoV-2 spike protein (S1 /S2) IgG in both the groups. SUBJECT RECRUITMENT: Healthy volunteers will be recruited into the study based on the inclusion criteria and the data shall be collected i.e. Demographics, comorbidities, date of vaccination will be entered in excel. They will be closely followed up to 120 days from the first dose of vaccination for COVID-19 to observe for any adverse reactions. RANDOMIZATION: Computer generated randomization DISCONTINUATION CRITERIA: People who become infected during the study period and lost to follow up are excluded. |
| Intervention type | Supplement |
| Primary outcome measure | Measured by blood test at baseline and 120 days: 1. Absolute lymphocyte count (CD3+, CD4+ and CD8+) 2. Anti-SARS-CoV-2 spike protein (S1 /S2) IgG |
| Secondary outcome measures | Safety of Curvic® with or without vaccine assessed through clinical biochemistry and by symptomatology at baseline and 120 days |
| Overall study start date | 21/03/2021 |
| Completion date | 28/02/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2021 |
| Date of final enrolment | 25/12/2021 |
Locations
Countries of recruitment
- India
Study participating centre
Above Abhishek Agro
Dindori Naka
Panchavati
Nashik
422008
India
Sponsor information
Industry
201/2, Old Kashmiri Building
R. R. Thakur Marg
Majas Wadi
Jogeshwari (E)
Mumbai
400060
India
| Phone | +91 9769057549 |
|---|---|
| director.ssvphytopharma@gmail.com | |
| Website | http://www.ssvphytopharma.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 05/03/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Raw data can be shared upon request by contacting yogesh_dound@yahoo.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | English version 1 |
09/03/2021 | 16/03/2022 | No | Yes |
| Participant information sheet | Marathi version 1 |
09/03/2021 | 16/03/2022 | No | Yes |
| Protocol file | version 1 | 09/03/2021 | 16/03/2022 | No | No |
Additional files
Editorial Notes
20/04/2022: Internal review.
16/03/2022: Trial's existence confirmed by Navsanjeevani Hospital Ethics Committee.
