COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002091-12/BG

HUVEPHARMA EOOD - Spas Petkov

Spas.Petkov@huvepharma.com

2020-05-05

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Male or female patients at least 18 years old 2. Signed informed consent 3. Admitted to hospital for treatment of COVID -19. The hospitalization must be for medical and not for social reasons. 4. Patient within 7 days from symptom onset and within 72 hours after laboratory diagnosis (SARS-CoV-2 RT-PCR) 5. Mild to Moderate COVID-19 disease defined as clinical status category 3 or 4 on the WHO 9-point ordinal scale Hospitalized, no oxygen treatment Oxygen by mask or nasal prongs 6. Presence of at least 1 symptom characteristic for COVID-19 disease, e.g. fever, cough, sore throat, myalgia, fatigue, GI disorders, skin lesions etc 7. In women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study

1. Critical patients with expected survival time < 72 hours 2. Presence of respiratory failure, shock, and/or combined failure of other organs that requires ICU monitoring 3. Participation in the trial is not in the patient`s best interest based on the judgement of the Investigator 4. Presence of the following laboratory values at screening White blood cell count <1,5X109/L Platelet count< 100000 mm3(<100 X109/L) Total bilirubin>2 X upper limit of normal (ULN) Alanine aminotransferase (ALT) or gamma glutamyl transferase (GGT) > 3 X ULN 5. Clinical suspicion for a bacterial superinfection at screening 6. Allergic or hypersensitive to the IMP or any of the ingredients 7. Patients who cannot take drugs orally, or have severe gastro-intestinal disorders, extensive bowel resection or bowel obstruction. 8. Previous (in the past 3 months) or concurrent use of any other Investigational product (IP) 9. Use of the prohibited medications during the treatment with IP, as defined in the protocol, 10. Patients with end stage liver disease (Child Pugh C score) 11. History or presence of serious or acute heart disease such as uncontrolled cardiac dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure (NYHA class III or 4) 12. Presence of acute stroke at screening or a history of acute stroke within the last 6 months. 13. Pregnant or breastfeeding 14. Legal incapacity, limited legal capacity, or any other condition that makes the patient unable to provide consent for the trial. 15. Patients who are institutionalized due to judicial order. 16. An employee or immediate relative of the Investigator or Sponsor. 17. Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including asthma and COPD), renal, hepatic, endocrine (including uncontrolled diabetes mellitus) or gastro-intestinal disorder, that according to Investigator could jeopardize the safety of the patient, or the integrity of the study

2

HUVEPHARMA EOOD

18

100

Bulgaria

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

120

Rate of subjects converted to negative SARS-CoV-2 (qualitative) test on Days 7

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2

[{"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]