COVID-19 trials registries data warehouse

https://rpcec.sld.cu/en/trials/RPCEC00000360-En

Mayra Garcia Carmenate

mayragc@infomed.sld.cu

2021-03-19

Not recruiting

RCT

Randomized

Single group assignment

Open label

single-center

Prevention

1. Both sexes. 2. Age between 19 and 80 years, extremes are included. 3. Subjects who grant their consent to participate

1. Individuals previously vaccinated with a vaccine candidate or SARS-CoV-2 vaccine. 2. Documented history of previous COVID-19 infection as a result of medical questioning. 3. Allergy to any of the components of the vaccine. 4. Administration of immunomodulators in the 30 days prior to vaccination. 5. Decompensated chronic diseases that limit vaccination. 6. Pregnancy, childbirth and the puerperium. 7. Acute illness that contraindicates vaccination 8. HIV subjects with detectable viral load, history of opportunistic infection or CD4 less than 200 copies.

1

Finlay Vaccine Institute (IFV)

19

80

Cuba

Healthy volunteers

N/A

150000

1. Virologically confirmed symptomatic infection of Covid-19. Measurement time: from 14 days after the candidate's last dose. 2. Confirmed Covid-19 infection with signs of severe systemic disease. Measurement time: from 14 days after the candidate's last dose. 3. Confirmed SARS-Cov-2 infection from routine surveillance or determinations of the presence of antigens. Measurement time: from 14 days after the candidate's last dose. 4. Death from causes directly attributable to a complication of COVID-19. Measurement time: from 14 days after the candidate's last dose. 5. Case Cumulative incidence: Measurement time: from 14 days after the candidate's last dose.

Not reported

[{"arm_notes": "25 \u00b5g+50 \u00b5g;2+1;Days0-28+day56", "treatment_id": 1519, "treatment_name": "Finlay-fr-1a anti-sars-cov-2 vaccine+finlay-fr-2 anti-sars-cov-2 vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]