COVID-19 trials registries data warehouse

https://www.isrctn.com/ISRCTN15779782

Ana Maria Henao Restrepo

henaorestrepoa@who.int

2021-10-08

Recruiting

RCT

Randomized

Adaptive

Blind label

multi-center

Prevention

1. Male or female participants between the ages of 16 and above at randomization 2. Living in the area and planning to reside in the area for at least 6 months 3. Capable of giving personal signed informed consent/have parent(s)/legal guardian capable of giving signed informed consent as described in SOP-03 4. Healthy participants who are determined by the clinical judgment of the investigator to be eligible for inclusion in the study 5. Participants who are willing and able to comply with all scheduled visits, vaccination plans, laboratory tests (if randomised and consent given, lifestyle considerations, and other study procedures

1. Previous laboratory-confirmed diagnosis of COVID 19. 2. Previous vaccination with any COVID-19 vaccine. 3. Receipt of medications intended to prevent COVID 19. 4. Participation in other studies involving a study intervention within 28 days prior to study entry and/or during study participation. 5. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). 6. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. 7. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 8. Women who are pregnant or breastfeeding will be informed that there is no data on the safety of these vaccines among these groups and will be given the opportunity to decide if they are willing to participate in the trial.

5

World Health Organization

16

100

Switzerland

Healthy volunteers

N/A

80000

Virologically confirmed COVID-19 disease; through SARS-CoV2 RNA isolation and RRT-PCR amplification in oro-nasopharyngeal specimen; regardless of disease severity; at 14; 180; 365 days after the last dose.

Phase 3

[{"arm_notes": "1, IM", "treatment_id": 1901, "treatment_name": "Arct-021", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1 or 2, Nasal", "treatment_id": 349, "treatment_name": "Covi-vac", "treatment_type": "Live attenuated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2, IM", "treatment_id": 653, "treatment_name": "Ino-4800", "treatment_type": "Dna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2, IM", "treatment_id": 840, "treatment_name": "Mvc-cov1901", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]