A clinical study to evaluate the efficacy of different anti-viral drugs in SARS-CoV-2 infected patients (COVID-19).
- Conditions
- SARS-COV-2 infectionMedDRA version: 21.1Level: LLTClassification code 10037373Term: Pulmonary disorderSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-000982-18-SE
- Lead Sponsor
- Karolinska University hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1218
1. Adult patients, 18 years and above
2. Confirmed SARS-2-CoV-2 infection by PCR
3. Admitted to the hospital ward or the ICU
4. Subjects provides written
informed consent prior to initiation of the study
5. No anticipated transfer within 72 hours to a non-study hospital
6. •If heterosexually active, men and women of child bearing potential must practice a highly effective method of birth control, including combined (estrogen and progestogen containing) hormonal prescription oral, intravaginal, transdermal contraceptives, or progestogen containing hormonal prescription oral, injectable, implantable contraceptives or intrauterine device (IUD), or intrauterine hormone-releasing systems (IUS), or male partner sterilization.
The above methods of contraception must be agreed to be used up to the last visit, Follow up 3 months.
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 609
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 609
1.Severe co-morbidity with life expectancy <3 months according to investigators assessment
2.ASAT/ALAT > 5 times the upper limit of normal
3.Acute co-morbidity within 7 days before inclusion such as myocardial infarction
4.Severe renal impairment, defined as an eGFR <40 mL/min
5.Known intolerance to the available study drugs
6.Pregnancy or breast feeding
7.Any reason why, in the opinion of the investigators, the patient should not participate
8.Subject participates in a potentially confounding drug or device trial during the course of the study
9.Prolonged QTc interval (>470 ms)
10.Cardiac heart failure (Ejection Fraction < 40%; uncompensated)
11.Electrolyte disturbances as hypocalcemia <4.65 mg/dL, hypokalemia <3.4 mmol/L, or hypomagnesia <1.7 mg/dL. However, if the electrolyte disturbances are corrected patient may be included with a delayed start of the test drug
12.Patients already receiving any of the study drugs
13.Patients diagnosed with psoriasis or porphyria
14.Patients receiving any of the following medications: dexametasone, haloperidol, carbamazepine, phenytoin, rifampin, phenobarbital, isoniazid, pyrazinamide, nevirapine, ritonavir, phenytoin or sodium valproate/valproic acid.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect of Remdesivir and Hydroxychloroquine on allcause<br>in-hospital mortality compared to standard of care.;Secondary Objective: - To assess the effect of Remdesivir and Hydroxychloroquine treatment<br>on hospital duration, receipt of ventilation or intensive care, and to<br>identify any serious adverse reactions.<br>- To assess the effect of Remdesivir and Hydroxychloroquine treatment<br>on 28 days mortality, viral clearance, kidney and myocardial failure, coinfections,<br>organ dysfunction and health-related Quality of Life.<br>;Primary end point(s): All-cause in-hospital mortality.;Timepoint(s) of evaluation of this end point: During hospitalisation.
- Secondary Outcome Measures
Name Time Method