NCT05475704

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2023

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

1.1 years

First QC Date

July 21, 2022

Last Update Submit

August 24, 2023

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • 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).

    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

    - 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

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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).

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

: Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC)

Buenos Aires, 1131, Argentina

Location

Clinica de la Costa Ltda.

Atlántico, Barranquilla, Colombia

Location

Clínica Medellín S.A.S

Medellín, Colombia

Location

Hospital General Regional Marcelino Velez Santana

Santo Domingo, Dominican Republic

Location

Instituto de Medicina Tropical Alexander von Humboldt at Universidad Peruana Cayetano Heredia

San Martín de Porres, Peru

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Thomas Verstraeten

    P95

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2022

First Posted

July 27, 2022

Study Start

May 23, 2022

Primary Completion

July 11, 2023

Study Completion

July 11, 2023

Last Updated

August 25, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)DO(1)CO(2)PE(1)