CIGB2020- ARI elderly contacts

Assessment of the effect and safety of CIGB2020 in asymptomatic subjects = 60 years old, contacts of patients diagnosed of acute respiratory infections (ARI), as compared to a control group from the same population (COVID-19) - PROFIRA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000356

Enrollment

1440

Registered

2021-03-11

Start date

2021-03-12

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Infection (ARI) COVID-19 SARS-CoV2

Interventions

Group I (Experimental): CIGB 2020 spray, by nasal route, an action of 0.1 mL in each nostril, repeat up to 5 times at intervals of 5 minutes (days 1 and 7). CIGB 2020 drops, by sublingual route, 5 dro

Immunotherapy, Active

Administration, Sublingual

Nasal Sprays

Administration, Intranasal

CIGB 2020 vaccine

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adults = 60 years old, both sexes. 2. All subjects = 60 years old, contacts of patients diagnosed with flu, cold, dengue fever, SARS-CoV2 or other acute respiratory infections to be randomized during the study. 3. Subjects having agreed their informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Diagnostic of SARS-CoV-2 infection since the day 14th previous to recruitment. 2. Use of immunosuppressor drugs during one month previous to recruitment. 3. Liver cirrhosis by HBV or liver transplant due to HBV. 4. Any problem avoiding the addequate follow-up of the contact older than sixty. 5. Terminal disease at the moment of recruitment. 6. History of allergy to some of the ingredients of the vaccine under study 7. Pregnancy or lactancy

Design outcomes

Primary

Measure	Time frame
Appearance of SARS CoV2 virus infection, flu or other febrile syndromes (Yes, No). Measurement time: 2 months.	—

Secondary

Measure	Time frame
For assessment 1. Time to the appearance of clinical symptoms. Measurement time: 2 months. 2. Nature and duration of the symptoms and their intensity. Measurement time: 2 months or during the symptomatic period. 3. Appearance of other infectious diseases. Measurement time: 2 months. 4. Hospitalization time. Measurement time: 2 months, or until the end of the hospitalization. For safety 5. Adverse Events-AE (Occurrence of an AE in the subject (Yes, No), Description of the AE (Name of the AE), Duration of the EA (Difference in dates between the start and end of the event), AE intensity (Mild, Moderate, Severe), Severity of the AE (Serious, Not serious), Attitude regarding the study treatment (No changes, Dose modification, Temporary interruption, Definitive interruption of the study treatment), AE result (Recovered, Improved, Persists, Sequelae), Causation relationship (Very Probable, Probable, Possible, Improbable, Not related, Not evaluable)). Measurement time: 1st hour, 24 hours and up to 28 days after the application of the product.	—

Measure

Time frame

For assessment 1. Time to the appearance of clinical symptoms. Measurement time: 2 months. 2. Nature and duration of the symptoms and their intensity. Measurement time: 2 months or during the symptomatic period. 3. Appearance of other infectious diseases. Measurement time: 2 months. 4. Hospitalization time. Measurement time: 2 months, or until the end of the hospitalization. For safety 5. Adverse Events-AE (Occurrence of an AE in the subject (Yes, No), Description of the AE (Name of the AE), Duration of the EA (Difference in dates between the start and end of the event), AE intensity (Mild, Moderate, Severe), Severity of the AE (Serious, Not serious), Attitude regarding the study treatment (No changes, Dose modification, Temporary interruption, Definitive interruption of the study treatment), AE result (Recovered, Improved, Persists, Sequelae), Causation relationship (Very Probable, Probable, Possible, Improbable, Not related, Not evaluable)). Measurement time: 1st hour, 24 hours and up to 28 days after the application of the product.

—

Countries

Cuba

Contacts

Public ContactMaria Marrero Miragaya

National Coordinating Center of Clinical Trials (CENCEC)

aceliac@cencec.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Apr 4, 2026