Status:
UNKNOWN
Optimization of Patients Long-term Management After the Coronavirus Infection COVID-19
Lead Sponsor:
Pirogov Russian National Research Medical University
Collaborating Sponsors:
Pfizer
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Brief Summary
200 participants should be included in the study. There will be three groups: 100 participants with a severe course of the disease 3 months ago, 50 asymptomatic carriers of coronavirus infection 3 mon...
Eligibility Criteria
Inclusion
- For all groups:
- Informed consent signed by the patient.
- Men and women aged 18 and over.
- Group COVID-19 (asymptomatic):
- Confirmed diagnosis of COVID-19 (positive SARS-CoV-2 RNA PCR test or history of IgM and / or IgG antibodies to SARS-CoV-2)
- Absence of any clinical symptoms associated with coronavirus infection.
- Group Healthy:
- Contact with patients with symptomatic new coronavirus infection COVID-19 in the absence of personal protective equipment for at least 3 days.
- Absence of any clinical symptoms associated with coronavirus infection
- Group COVID symptomatic:
- Confirmed diagnosis of previous COVID-19 (positive SARS-CoV-2 RNA PCR test or presence of IgM antibodies to SARS-CoV-2) in history.
- A severe course of COVID-19, characterized by one or more of the following symptoms:
- Respiratory rate ≥ 30 in 1 min
- Blood oxygen saturation (SpO2) ≤ 93%
- The ratio of the partial tension of oxygen in arterial blood to the fraction of oxygen during inspiration (PaO2 / FiO2) \<300
- Lung tissue lesion\> 50% and / or according to computed tomography CT-2 and higher
- Septic shock / sepsis
- Development of multiple organ failure
- Cytokine storm
Exclusion
- Pregnancy
- Covid-19 vaccination
- Any serious medical illness before coronavirus infection, as well as a permanent form of atrial fibrillation
- Regular intake of anti-inflammatory, antibacterial, cytostatic and immunosuppressive drugs
- Refusal to participate in the study
Key Trial Info
Start Date :
January 20 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 15 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04871789
Start Date
January 20 2021
End Date
June 15 2021
Last Update
May 4 2021
Active Locations (1)
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1
Russian Clinical Research Center for Gerontology
Moscow, Russia, 129226