Clinical trial to evaluate the tolerability, efficacy and safety of Aesculus Hippocastanum L seed extract in COVID-19 patients with mild pneumonia

Phase 1

• Conditions: COVID-19 patients with mild pneumonia; MedDRA version: 23.1Level: PTClassification code 10084380Term: COVID-19 pneumoniaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2022-001097-64-LT
• Lead Sponsor: AB Švencioniu vaistažoles

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-22
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patient age: 18 to 65 years
2. The patient gave informed consent; patients who understand the essence of the study
and can independently give the informed consent
3. A positive SARS-CoV-2 sample (nasopharyngeal swab) was determined by RT-PCR
4. Patients diagnosed with mild pneumonia with no identified lesions by chest X-ray
5. Patients who have a fever
6. Premenopausal women who had a negative pregnancy test
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

1. Fever 37.5 °C more than 14 days after the onset of fever
2. Patients with SpO2 less than 95 % and not treated with O2 therapy
3. Patients with suspected co-fungal infection
4. Patients with congestive heart failure
5. Patients with severe hepatic impairment.
6. Patients with renal insufficiency
7. Patients with impaired consciousness, such as those with dementia
8. Pregnant women
9. Women patients intending to breast-feed
10. Patients with a gout or with hyperuricemia
11. Patients taking immunosuppressants, cancer patients
12. Patients with a recurrent SARS-CoV-2 infection
13. Patients with epilepsy, bronchial asthma
14. Unstable angina pectoris or myocardial infarction within 30 days prior to screening
15. Patients participating in another clinical trial or if participation finished before 3
months
16. Patients have blood purification therapies (hemodialysis, hemofiltration,
hemadsorption, plasma exchange, plasma adsorption, peritoneal dialysis, etc.)
17. Patients who develops a disease with diarrhea syndrome
18. Other patients who have been assessed as unfit by the principal investigator or
designated physician

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified