Covid19 Clinical Trial
— VARICOVIDOfficial title:
Comparison of Mortality in Severe SARS-Cov-2 Infection Caused by the 501Y.V2 Variant and B.1.1.7 Variant
| NCT number | NCT04906850 |
| Other study ID # | 2021-05Obs-CHRMT |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 1, 2021 |
| Est. completion date | May 15, 2021 |
| Verified date | May 2021 |
| Source | Centre Hospitalier Régional Metz-Thionville |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
In January 2021, the incidence of COVID-19-and its mortality started rising for the third time in France. This rise may associate with three emerging variants, namely, V1, V2, and V3, which are the 20I/501Y.V1 ("English"), 20H/501Y.V2 ("South African"), and 20J/501Y.V3 ("Brazilian") variants, respectively. V1 was recently suggested to increase mortality in people in the United Kingdom who tested positive for COVID-19 on community screening. Very little is known about V2 infection, including its outcomes relative to other strains. In early 2021, V2 spread to the Grand-Est region (northeastern France). Here, the investigators aimed to report mortality data of patients admitted in ICU between February and April 2021 in 3 hospitals in Grand-Est: Metz, Thionville and Nancy.
| Status | Completed |
| Enrollment | 250 |
| Est. completion date | May 15, 2021 |
| Est. primary completion date | April 15, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Admission in ICU in February, March or April 2021 - Patient with a SARS-CoV-2 positive polymerase-chain reaction test - Patient with 20I/501Y.V1 ("English") or 20H/501Y.V2 ("South African") SARS-CoV-2 variants Exclusion Criteria: - Opposed to use data |
| Country | Name | City | State |
|---|---|---|---|
| France | CHR Metz Thionville | Metz | Moselle |
| France | CHRU Nancy | Nancy | Meurthe-et-moselle |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Régional Metz-Thionville | Central Hospital, Nancy, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mortality 28 days after admission | Vital status 28 days after admission in Intensive Care Unit | Day 28 | |
| Secondary | ICU mortality | Percentage of mortality in Intensive Care Unit | Day 1 |
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