| Trial registration number
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RPCEC00000363 |
Full text link
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://rpcec.sld.cu/en/trials/RPCEC00000363-En
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First author
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Sonia Resik Aguirre
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Contact
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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sresik@ipk.sld.cu
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Registration date
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-03-27
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Recruitment status
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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nonRCT
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Allocation
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Non-randomized
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Design
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Single group assignment
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Masking
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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multi-center
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Study aim
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Subjects of both sexes. 2. Age between 19 and 80 years, extremes are included. 3. Subjects who grant their consent to participate.
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Exclusion criteria
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Individuals previously vaccinated with a vaccine candidate or SARS-CoV-2 vaccine. 2. Documented history of previous COVID-19 infection by medical questioning. 3. Allergy to any of the components of the vaccine. 4. Administration of immunosuppressants in the 30 days prior to vaccination 5. Decompensated chronic diseases that limit vaccination. 6. Pregnancy, puerperium and lactation. 7. Acute illness that contraindicates vaccination. 8. HIV positive subject with detectable viral load, opportunistic disease or CD4 + count less than 200 copies (according to the last follow-up check of the patient).
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Number of arms
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1
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Funding
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Center for Genetic Engineering and Biotechnology (CIGB)
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Inclusion age min
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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19
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Inclusion age max
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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80
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Countries
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Cuba
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Type of patients
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy volunteers
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Severity scale
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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124000
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primary outcome
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Virologically confirmed symptomatic infection of Covid-19 (Yes/No). Measurement time: from 14 days after the administration of the third dose of CIGB-66; for 4 months. 2. Confirmed Covid-19 infection with signs of severe systemic disease (Yes/No). Measurement time: from 14 days after the administration of the third dose of CIGB-66; for 4 months. 3. Confirmed SARS-Cov-2 infection from routine surveillance (Yes/No). Measurement time: from 14 days after the administration of the third dose of CIGB-66; for 4 months. 4. Death from causes directly attributable to a complication of COVID-19 (Yes No). Measurement time: from 14 days after the administration of the third dose of CIGB-66; for 4 months. 5. Global burden of incidence: Cumulative incidence of cases in the observation period. Measurement time: from 14 days after the administration of the third dose of CIGB-66; for 4 months.
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Notes
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Arms
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 1975, "treatment_name": "Cigb-66", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]
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