COVID-19NCT05475704
Effectiveness of Chinese COVID-19 Vaccines in Latin America and the Caribbean
An observational study of COVID-19, run by P95 at 5 sites in 4 countries.
Trial summary
This multi-country study seeks to collect real-world evidence (RWE), from Latin American and Caribbean countries, on the effectiveness of China-made COVID-19 vaccines in different populations, against different clinical outcomes, and when administered in different schedules. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 59 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 23 May 2022to 11 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18 years old and older that present to the emergency room ("emergency room visit") or are hospitalized with Severe Acute Respiratory Infection (SARI).
Who may be able to join
- Patients need to fulfill all the following criteria to be eligible for the study:
- Being 18 years old or older
- Ever eligible for vaccination2 with any of the Chinese COVID-19 vaccines provided in their country as per national/regional immunization recommendations prior to hospital admission
- ER consultation or hospitalization due to SARI
- Willing and able to provide informed consent (or by a legally accepted representative if the patient is not able to provide a signature by him/herself)
Who cannot join
- Patients that fulfill one or more of the following criteria will not be eligible for the study:
- Patients vaccinated against COVID-19 but not with the vaccines of interest
- Patients admitted or hospitalized for other condition than SARI
- Patients to whom it is not possible to perform a diagnostic test (antigen or PCR) for SARS-CoV-2
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Colombia2 sites
Clinica de la Costa Ltda.
Atlántico, Barranquilla
Clínica Medellín S.A.S
Medellín
Argentina1 site
: Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC)
Buenos Aires, 1131
Dominican Republic1 site
Hospital General Regional Marcelino Velez Santana
Santo Domingo
Peru1 site
Instituto de Medicina Tropical Alexander von Humboldt at Universidad Peruana Cayetano Heredia
San Martín de Porres
About this study
This multi-country study seeks to collect real-world evidence (RWE), from Latin American and Caribbean countries, on the effectiveness of China-made COVID-19 vaccines in different populations, against different clinical outcomes, and when administered in different schedules.
Read the detailed description
This multi-country study seeks to collect RWE, from Latin American and Caribbean countries, on the effectiveness of China-made COVID-19 vaccines in different populations, against different clinical outcomes and when administered in different schedules.
The vaccines of interest are the following:
- 'Sinovac-CoronaVac' (Sinovac Biotech Ltd., Beijing, China),
- 'BIBP COVID-19 Vaccine' ('Covilo'; 'BIBP-CorV') (Sinopharm, Beijing Institute of Biological Products, China),
- 'Convidecia' ('AD5-nCOV') (CanSino Biologics, Tianjin, China).
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Test-positive cases are study participants that meet the SARI case definition AND test positive for at least one SARS-CoV-2 diagnostic test, with specimens collected up to 14 days prior to ER visit or hospitalization or up to 24 hours thereafter | |
| Control group | Test-negative controls are study participants that meet the SARI case definition AND test negative for all SARS-CoV-2 diagnostic test with specimens collected up to 14 days prior to ER visit or hospitalization or up to 24 hours thereafter |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 detection
The outcome of interest for the primary analysis will be the SARS-CoV-2 detection from study participants who present to the ER ("ER visit") or are hospitalized with SARI, as determined through the standard of care diagnostic testing (i.e., antigen test or PCR).
Measured: Specimen collected between d-14 and d0, where d0 is the day at ER visit or hospital admission (or specimen collected within 24 hours upon arrival at the hospital)
Secondary outcomes (1)
Level of disease severity
Level of disease severity of participants will be characterized according to the WHO COVID-19 Clinical Progression Scale:
- Ambulatory mild disease, without death
- Hospitalized (moderate disease) without in-hospital death
- Hospitalized (ICU, severe disease) without in-hospital death
- In-hospital death (including death in the ER)
Measured: - The Time Frame will be defined as the time from ER/Hospital admission to the date of hospital discharge or date of death at hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start23 May 2022
- Primary completion11 Jul 2023
- Study completion11 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- P95
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centers for Disease Control and Prevention, China
- Responsible party
- Sponsor
- Investigators
- Thomas Verstraeten, Principal investigator, P95
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475704
- Sponsor's protocol ID
- PRJ000284
- Status last verified
- Aug 2023
- First submitted
- 21 Jul 2022
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Chinese COVID-19 Vaccines in Latin America and the Caribbean
- ClinicalTrials.gov ID
- NCT05475704
- Acronym / sponsor ID
- PRJ000284
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- P95Industry (pharma, biotech, devices)
- Collaborators
- Centers for Disease Control and Prevention, China
- Study start
- 23 May 2022 (actual)
- Primary completion
- 11 Jul 2023 (actual)
- Study completion
- 11 Jul 2023 (actual)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-country study seeks to collect real-world evidence (RWE), from Latin American and Caribbean countries, on the effectiveness of China-made COVID-19 vaccines in different populations, against different clinical outcomes, and when administered in different schedules.
Detailed description
This multi-country study seeks to collect RWE, from Latin American and Caribbean countries, on the effectiveness of China-made COVID-19 vaccines in different populations, against different clinical outcomes and when administered in different schedules.
The vaccines of interest are the following:
- 'Sinovac-CoronaVac' (Sinovac Biotech Ltd., Beijing, China),
- 'BIBP COVID-19 Vaccine' ('Covilo'; 'BIBP-CorV') (Sinopharm, Beijing Institute of Biological Products, China),
- 'Convidecia' ('AD5-nCOV') (CanSino Biologics, Tianjin, China).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | –Test-positive cases are study participants that meet the SARI case definition AND test positive for at least one SARS-CoV-2 diagnostic test, with specimens collected up to 14 days prior to ER visit or hospitalization or up to 24 hours thereafter |
| Control group | – | –Test-negative controls are study participants that meet the SARI case definition AND test negative for all SARS-CoV-2 diagnostic test with specimens collected up to 14 days prior to ER visit or hospitalization or up to 24 hours thereafter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years old and older that present to the emergency room ("emergency room visit") or are hospitalized with Severe Acute Respiratory Infection (SARI).
Key inclusion criteria (5 listed)
- Being 18 years old or older
- Ever eligible for vaccination2 with any of the Chinese COVID-19 vaccines provided in their country as per national/regional immunization recommendations prior to hospital admission
- ER consultation or hospitalization due to SARI
- Willing and able to provide informed consent (or by a legally accepted representative if the patient is not able to provide a signature by him/herself)
Key exclusion criteria (4 listed)
- Patients that fulfill one or more of the following criteria will not be eligible for the study:
- Patients vaccinated against COVID-19 but not with the vaccines of interest
- Patients admitted or hospitalized for other condition than SARI
- Patients to whom it is not possible to perform a diagnostic test (antigen or PCR) for SARS-CoV-2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SARS-CoV-2 detection
Time frame: Specimen collected between d-14 and d0, where d0 is the day at ER visit or hospital admission (or specimen collected within 24 hours upon arrival at the hospital)
The outcome of interest for the primary analysis will be the SARS-CoV-2 detection from study participants who present to the ER ("ER visit") or are hospitalized with SARI, as determined through the standard of care diagnostic testing (i.e., antigen test or PCR).
1 secondary outcome
Level of disease severity
Time frame: - The Time Frame will be defined as the time from ER/Hospital admission to the date of hospital discharge or date of death at hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Verstraeten principal investigator
P95
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by P95 at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Colombia, Argentina, Dominican Republic, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 detection (time frame: Specimen collected between d-14 and d0, where d0 is the day at ER visit or hospital admission (or specimen collected within 24 hours upon arrival at the hospital)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.