Status:
COMPLETED
Efficacy of Adaptogens in Patients With Long COVID-19
Lead Sponsor:
Swedish Herbal Institute AB
Collaborating Sponsors:
National Family Medicine Training Centre, Georgia
Tbilisi State Medical University
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The aim of this clinical trial of a fixed combination of standardized extracts from Rhodiola rosea roots, Schisandra chinensis berry and Eleutherococcus senticosus root (ADAPT-232) in COVID-19 patient...
Detailed Description
Rationale. Currently, numerous clinical trials on efficacy antiviral preparations in COVID-19 patients are in progress, however little is known on effective treatment of comorbid complications or COVI...
Eligibility Criteria
Inclusion
- COVID-19 patients with confirmed diagnosis based on positive SARS-Cov-2 test and the symptom of at least three of Long COVID-19 symptoms including: fatigue, headache, respiration problems (dyspnea or polypnea), sweat, cognitive disorders (attention, memory, anxiety and depression), loss of smell (anosmia) and taste (ageusia), cough, pain in joints. muscles and chest.
- Post COVID-19 patients discharged from Covid Hotels isolation, after hospitals and Intensive Care Unit (ICU) admission.
- Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient).
- Able to take medication alone.
- Able to give informed consent.
Exclusion
- Post COVID-19 patients discharged from Covid Hotels isolation, after hospitals and Intensive Care Unit (ICU) admission and Long Covid Symptoms longer that 3 months.
- Patient admitted already under invasive mechanical ventilation;
- Patient admitted with severe acute respiratory syndrome and diagnosed with an etiologic agent other than SARS-CoV-2;
- Renal failure requiring dialysis or creatinine ≥ 2.0mg/dl;
- Tube feeding or parenteral nutrition.
- Respiratory decompensation requiring mechanical ventilation.
- Uncontrolled diabetes type 2.
- Autoimmune disease.
- Pregnant or lactating women.
- Taking antibiotics for a reason other than COVID-19 at enrollment;
- Has a chronically weakened immune system (AIDS, lymphoma, chemo-radio- corticosteroid therapy, immunosuppressive pathology);
- Was treated with chemo-radio-corticosteroid therapy in the last 6 months;
- Has active cancer;
- Taking immunosuppressive drugs (e.g. anti-rejection treatment after organ transplant);
- Already participating in another clinical trial;
- Has any other condition that would prevent safe participation in the study.
Key Trial Info
Start Date :
April 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04795557
Start Date
April 19 2021
End Date
December 26 2021
Last Update
December 28 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Family Medicine Training Centre,
Tbilisi, Georgia, 0102