Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04357496 |
| Other study ID # |
COVER-2020 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 2021 |
| Est. completion date |
May 2021 |
Study information
| Verified date |
May 2021 |
| Source |
CENTOGENE GmbH Rostock |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
A national, observational, longitudinal, non-interventional program aiming to identify
prognostic parameters, to investigate the kinetics of the immune response, and to identify
predictive biomarkers in SARS-CoV-2 infected patients.
Description:
By 31st December 2019, 27 subjects with pneumonia of unknown aetiology were registered in
Wuhan City, China. 7th of January the disease causative agent was identified and turned to be
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The WHO named the disease -
coronavirus disease (COVID-19). On March 11, 2020, the World Health Organization (WHO)
announced that COVID-19 should be characterized as a pandemic. At great economic cost, many
countries have adopted unprecedented measures to curb the spread of the virus, such as
large-scale use of isolation and quarantine, closing borders, imposing limits on public
gatherings, and implementing nationwide lockdowns.
The most common symptoms of COVID-19 are fever, tiredness, and dry cough. Some patients may
exhibit nasal congestion, runny nose, sore throat or diarrhea. These symptoms are usually
mild and begin gradually. About 40% of the symptomatic patients recover from the disease
without needing special treatment. Around 1 out of every 6 people infected with SARS-CoV-2
becomes seriously ill and develops difficulty breathing. Older people, and those with
underlying medical problems like high chronic cardiovascular and respiratory disease or
diabetes, are more likely to develop serious illness.
Monitoring patients with resolution of COVID-19 pneumonia is important in terms of when they
should be released from isolation and discharged and to what extent this result is
correlating with the clinical severity. If patients are still shedding viable coronavirus,
they are likely to infect others. Therefore, quarantine for up to one month may be advisable.
The optimal method for test of cure most likely will be two consecutive negative real-time
RT-PCR tests. Furthermore, people who have cleared SARS-CoV-2 could have developed specific
antibodies against the infectious agent in their blood plasma as a result of humoral immune
response. This plasma is rich with specific antibodies and is called convalescent plasma (CP)
or convalescent serum (CS). CP could treat and eradicate SARS-CoV-2 in infected individuals
and could be used as therapy. This therapy concept was centuries old and was previously
attempted during several outbreaks. Currently, there are few reports from China and South
Korea showing that patients who received CP transfusion together with antiviral drugs and
corticosteroids have recovered from the disease.
It is the aim of the COVeR study to enroll 400 patients with COVID-19 from nursing homes of
the german state Mecklenburg-Vorpommern. Each patient will enter a follow-up phase of 6
months during which buccal swaps will be collected for judging the viral load, and blood
samples for investigation of their immune response and identifying predictive biomarkers.
