Evaluation of the efficacy, safety and tolerability of alisporivir for the treatment of hospitalised patients with infections due to SARS-CoV-2 (COVID-19).
- Conditions
- The study population will consist of adults (18-80 years old) hospitalised for =48 hours prior to randomisation with a diagnosis of COVID-19 based on symptoms onset and SARS-CoV-2 RT-PCR test positive from nasopharyngeal swab. Patients with ARDS or patients requiring mechanical ventilation at screening or randomisation will be excludedMedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-002295-13-FR
- Lead Sponsor
- Assistance Publique - Hôpitaux Paris
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
1.Adult males and females =18 years and =80 years of age at the time of screening.
2.Are hospitalised during the screening period with duration of hospitalisation prior to randomisation =48 hours.
3.Have a diagnosis of COVID-19 based on symptoms onset and SARS-CoV-2 RT-PCR test positive from nasopharyngeal swab.
4.Have at least one (1) of the following:
a.Radiographic pulmonary infiltrates (CT scan), AND/OR
b.Clinical assessment (evidence of rales/crackles on exam) AND SpO2 =94% on room air, AND/OR
c.Requirement of supplemental oxygen.
5.If female, of non-childbearing potential (e.g. post-menopausal as demonstrated by FSH or surgical sterilization i.e., tubal ligation or hysterectomy), or if of childbearing potential, be willing to commit to either sexual abstinence or use of at least 2 medically accepted, effective methods of birth control (e.g., condom, spermicidal gel, oral contraceptive, indwelling intrauterine device, hormonal implant/patch, injections, approved cervical ring) from screening through 7 months after last alisporivir dose.
6.If male, a willingness to refrain from donating sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, a willingness to use a condom in addition to having the female partner use a highly effective method of birth control (such as an intrauterine device, diaphragm, oral contraceptives, injectable progesterone, subdermal implants, or a tubal ligation) from screening through 4 months after last alisporivir dose.
7.Willing and able to provide written informed consent.
8.Willing to comply with all study assessments and adhere to the protocol schedule.
9.Has an affiliation with a social security system.
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
1.Patients with ARDS or patients requiring mechanical ventilation at screening or randomisation.
2.In the opinion of the investigator, the patient is unlikely to survive the following 7 days after randomisation due to a rapidly progressive or terminal illness with a high risk of mortality due to any cause, including acute hepatic failure, respiratory failure or severe septic shock.
3.Patients who are unconscious or considered by the investigator unable to consent.
4.Other severe co-morbidity with life expectancy =3 months according to the investigator’s assessment.
5.Critically ill patients who have an APACHE II score =30.
6.Concomitant severe bacterial infection including blood stream infections, endocarditis, osteomyelitis, retroperitoneal abscess, septic arthritis, or meningitis diagnosed within 7 days prior to randomisation (bacterial pulmonary infection that may complicate COVID-19 is not an exclusion criterion).
7.Any of the following signs of severe sepsis:
a.Shock or profound hypotension defined as systolic blood pressure =90 mm Hg or a decrease of =40 mm Hg from the value obtained during screening (if more than one measurement is taken) that is not responsive to fluid challenge.
b.Hypothermia (core temperature = 35.6°C).
c.DIC as evidenced by PT, PTT 2 × ULN, or platelets = 50% of the LLN.
8.History of positive test for HIV including all patients currently on HAART regardless of the CD4+ cell count.
9.Presence of immunodeficiency or an immunocompromised condition including neutropenia (=1,000 neutrophils/mm3 obtained from the local laboratory at screening), haematologic malignancy, history of haematopoietic stem cell transplant, history of solid organ transplant, receiving immunosuppressive therapy (e.g. cancer chemotherapy, mAbs for autoimmune disease, or medications to prevent transplant rejection), and long term use of systemic corticosteroids (e.g., =20 mg/day of prednisone or systemic equivalent for at least 2 weeks).
10.Severe hepatic impairment at screening, as evidenced by ALT or AST =3 × ULN or total bilirubin =2 × ULN (except in case of known Gilbert syndrome), or clinical signs of cirrhosis or end-stage hepatic disease (e.g., ascites, hepatic encephalopathy).
11.Acute hepatitis, cirrhosis (any Child-Pugh class), acute hepatic failure or acute decompensation of chronic hepatic failure.
12.Alkaline phosphatase =3.0 × ULN. Patients with values =3.0 × ULN and =5.0 × ULN are eligible if this value is documented to be acute and directly related to the infectious process being treated.
13.Severe renal impairment (creatinine-clearance =30 mL/min) or ESRD requiring haemodialysis or peritoneal dialysis, according to Cockcroft-Gault.
14.Uncontrolled hypertension (systolic blood pressure =150 mmHg or diastolic blood pressure =90 mmHg).
15.Uncontrolled thyroid function (TSH, free T3 or free T4 outside of normal ranges).
16.History of known or suspected Clostridium difficile infection.
17.History of epilepsy or known seizure disorder (excluding a history of childhood febrile seizures).
18.Acute co-morbidity within 7 days before inclusion such as myocardial infarction.
19.A female who is pregnant or breastfeeding.
20.Documented hypersensitivity reaction or anaphylaxis to alisporivir, one of the non-active ingredients or any of the SOC medications.
21.Receipt of any investigational medication in the 3 months prior to screening.
22.Anticipated transfer to another hospital that is not
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method