Amiodarone or Verapamil in COVID-19 hospitalized patients with symptoms: Randomized clinical trial

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 804

Inclusion Criteria

1)Hospitalized patients with confirmed COVID-19 and symptoms. Confirmation of COVID-19 diagnosis should be made with Real-Time PCR.
2)Written informed consent given prior to any trial-related procedure.
3)Male and female age 18 or more at the time of signing the informed consent.
4)An oxygenation index defined as quotient of partial pressure of oxygen in arterial blood (PaO2, in mmHg) and fraction of inspired oxygen (FiO2) > 200.
5)Willingness and ability to comply with the protocol.
6)Contraception and fertility:
A.Female patients:
-must be of non-child-bearing potential i.e. surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before screening/enrolment) or post-menopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause), or
-if of child-bearing potential, must have a negative pregnancy test before the first IMP intake (blood / urine pregnancy test). They must agree not to attempt to become pregnant, must not donate ova, and must use a highly effective contraceptive method (see below) together with a barrier method during the clinical trial.

B.Male patients must agree not to father a child or to donate sperm starting at Screening, during the clinical trial. Male patients must also
-abstain from sexual intercourse with a female partner (acceptable only if it is the patient’s usual form of birth control/lifestyle choice), or
-use adequate barrier contraception during treatment with the IMP, and
-if they have a female partner of childbearing potential, the partner should use a highly effective contraceptive method.
-if they have a pregnant partner, they must use condoms while taking the IMP to avoid exposure of the fetus to the IMP

Highly effective methods of contraception meaning.
Highly effective forms of birth control are those with a failure rate less than 1% per year and include:
-oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraceptives associated with inhibition of ovulation
-oral, injectable, or implantable progestogen-only hormonal contraceptives associated with inhibition of ovulation
-intrauterine device or intrauterine hormone-releasing system
-bilateral tubal occlusion
-vasectomized partner (i.e. the patient’s male partner underwent effective surgical sterilization before the female patient entered the clinical trial and is the sole sexual partner of the female patient during the clinical trial)
-sexual abstinence (acceptable only if it is the patient’s usual form of birth control/lifestyle choice; periodic abstinence [e.g. calendar, ovulation, symptothermal, postovulation methods] and withdrawal are no acceptable methods of contraception)

Barrier methods of contraception include:
-Condom (without spermicidal foam/gel/film/cream/suppository or fat- or oil-containing lubricants)
-Occlusive cap (diaphragm or cervical/vault caps) with spermicidal gel/film/cream/suppository.

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 804
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Acute respiratory distress syndrome (ARDS).
2)Contraindications for or known hypersensitivity to amiodarone or calcium channel blockers.
3)Long QT syndrome.
4)Prolonged baseline QTc interval (=450 ms).
5)Cardiogenic shock or severe hypotension (< 90 mmHg).
6)Severe left ventricle dysfunction (left ventricular ejection fraction =35%).
7)Severe sinus - node dysfunction with marked sinus bradycardia.
8)2nd/3rd degree heart block.
9)Bradycardia without pacemaker that has caused syncope.
10)History of severe dysthyroidism. Clinical signs and symtomps of thyroid disease if there are abnormal TSH and thyroxine (fT4)or triiodothyronine (fT3) levels in serum.
11)A-Fib/flutter conducted via accessory pathway (ie,Wolff -Parkinson-White).
12)Women who are pregnant or breastfeeding at study screening.
13)Patient with concurrent disease considered by the Investigator to be clinically significant in the context of the study.
14)Severe mental illness and/or a history or evidence of organic brain disease or dementia considered by the Investigator to be clinically significant in the context of the study, that would compromise the subject’s ability to comply with the study protocol.

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

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