- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04789356
Effectiveness of the Adsorbed Vaccine COVID-19 (Coronavac) Among Education and Public Safety Workers With Risk Factors for Severity (COVACMANAUS)
22. juli 2021 oppdatert av: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Phase IV Study to Evaluate the Effectiveness of the Inactivated Adsorbed Vaccine Against COVID-19 CoronaVac, Among Public Safety and Education Workers With Risk Factors for Severity, in Manaus (Amazonas)
This is a quasi-experimental study with risk-based allocation.
Public security and education professionals from the state government will be included.
In the initial evaluation, the presence of comorbidities associated with an increased risk of serious disease due to COVID-19 will be evaluated, according to the national plan for the implementation of vaccination against COVID-19.
Those with at least one of these comorbidities will be invited to receive the study vaccine in two doses, with an interval of 28 days (±7 days).
Participants with low risk (without comorbidities as a risk factor for severe COVID-19 according to the national plan for the implementation of vaccination against COVID-19) will not receive the vaccine within the scope of the research project.
If, after 12 months, the participant in the low-risk group (no vaccine) has not received CoronaVac, or any other vaccine available, he/she will receive the vaccine, exactly as offered in the other group (two doses of CoronaVac with an interval of 28 days - with a tolerance of 7 days before or after).
All participants will be followed up for 12 months from inclusion in the study.
Immunization is expected to reduce the risk of moderate to severe disease of those with comorbidities to the level of those of the same age group who do not have these comorbidities but face similar occupational risks.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
6233
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Amazonas
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Manaus, Amazonas, Brasil, 69050-010
- Escola Normal Superior - Universidade do Estado do Amazonas
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 49 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Age between 18 and 49 years
- Demonstrate availability to be accompanied during the follow-up time defined in the study, through visits, telephone contacts, or other means of digital communication.
Exclusion Criteria:
- Prior vaccination for COVID-19;
- Diagnosis of COVID-19 in the last 28 days (nasal and oropharyngeal swab);
- History of severe allergic reaction or anaphylaxis to study vaccine components;
- Report of fever in the 72 hours prior to vaccination (the inclusion may be postponed until the participant completes 72 hours without fever);
- Possible or confirmed of COVID-19 on the day of vaccination (in this situation, vaccination can be postponed until the participant completes 72 hours without symptoms or the diagnosis is ruled out);
- Have received live attenuated virus vaccine in the last 28 days or inactivated vaccine in the last 14 days prior to inclusion in the study, or have immunization scheduled for the first 28 days after their inclusion in the study;
- Any other condition that, in the opinion of the principal investigator or his medical representative, could endanger the safety or rights of a potential participant or that would prevent him or her from complying with this protocol;
- Pregnancy or breastfeeding.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: High-risk individuals (with comorbidities)
Public safety and security (police officers and law enforcement, fire department), and high school and college/university professionals of the state government public education network who present at least one of the comorbidities included in the National Plan for the Operationalization of Vaccination Against COVID-19 will be invited to receive the CoronaVac vaccine
|
600 SU/dose; Two doses separated by 28 days (± 7 days).
Intramuscular (deltoid) administration.
Andre navn:
|
Ingen inngripen: Low-risk individuals (without comorbidities)
Participants with low risk (without comorbidities as a risk factor for severe COVID-19 according to the national plan for the implementation of vaccination against COVID-19) will not receive the vaccine within the scope of the research project.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Incidence density of moderate and severe clinical cases of COVID-19
Tidsramme: 2 weeks after the second vaccine dose
|
Incidence density of moderate and severe clinical cases of COVID-19 (Grade 4 or higher according to the WHO clinical progression scale), after the second week after the second dose of the vaccine.
|
2 weeks after the second vaccine dose
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Incidence density of moderate and severe clinical cases of COVID-19 after first dose
Tidsramme: After first dose, up to 12 months.
|
Incidence density of moderate and severe clinical cases of COVID-19 (grade 4 or higher according to the WHO clinical progression scale) from the first dose
|
After first dose, up to 12 months.
|
Incidence density of moderate and severe clinical cases of COVID-19 after second dose
Tidsramme: After second dose, up to 12 months.
|
Incidence density of moderate and severe clinical cases of COVID-19 (grade 4 or higher according to the WHO clinical progression scale) from the second dose
|
After second dose, up to 12 months.
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Incidence density of severe clinical cases of COVID-19 after second dose
Tidsramme: After second dose, up to 12 months.
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Incidence density of severe clinical cases of COVID-19 (grade 6 or higher according to the WHO clinical progression scale) from the second dose
|
After second dose, up to 12 months.
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Median of clinical progression scores between moderate and severe cases
Tidsramme: After first dose, up to 12 months.
|
Comparison of the median clinical progression scores according to the WHO clinical progression scale between groups
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After first dose, up to 12 months.
|
Incidence density of clinical cases virologically confirmed as COVID-19
Tidsramme: After first dose, up to 12 months.
|
After first dose, up to 12 months.
|
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Mortality confirmed as COVID-19
Tidsramme: After first dose, up to 12 months.
|
Incidence density of deaths confirmed as COVID-19
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After first dose, up to 12 months.
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Incidence density of hospitalizations for any cause
Tidsramme: After first dose, up to 12 months.
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After first dose, up to 12 months.
|
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Mortality from any cause
Tidsramme: After first dose, up to 12 months.
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Density of mortality from any cause
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After first dose, up to 12 months.
|
Adverse events
Tidsramme: Up to 7 days after each dose of the vaccine (Day 7 and Day 35)
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Frequency of adverse events associated with the need for medical care
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Up to 7 days after each dose of the vaccine (Day 7 and Day 35)
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Humoral and cell-mediated immune response
Tidsramme: Before each vaccine dose and every 3 months, up to 12 months of follow-up.
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Quantification of humoral and cell-mediated immune response to vaccination in samples of a subgroup of participants
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Before each vaccine dose and every 3 months, up to 12 months of follow-up.
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Detection of antibodies against SARS-CoV-2 in samples
Tidsramme: Before each vaccine dose and every 3 months, up to 12 months of follow-up
|
Before each vaccine dose and every 3 months, up to 12 months of follow-up
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Marcus Lacerda, MD, Fundação de Medicina Tropical Heitor Vieira Dourado
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
18. mars 2021
Primær fullføring (Faktiske)
5. juli 2021
Studiet fullført (Forventet)
1. mars 2022
Datoer for studieregistrering
Først innsendt
5. mars 2021
Først innsendt som oppfylte QC-kriteriene
8. mars 2021
Først lagt ut (Faktiske)
9. mars 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. juli 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. juli 2021
Sist bekreftet
1. juli 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CAAE: 44076721.5.0000.0005
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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