COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04530422

Mohamed Abdelsalam El-Gohary

Not reported

2020-08-28

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - pneumonic patients with sars-cov-2 infection confirmed to be positive by rt-pcr; and demonstrated moderate cases criteria (fever "measured temperature of at least 38 °c", lower respiratory symptoms "cough, shortness of breath" and imaging-confirmed pneumonia"). - female patients enrolled in the study should have no planned pregnancy for 6 months, after participating in the study, with administration of proper contraceptive measures within 30 days from the first therapeutic dose of the investigational drugs. - patients agreed to sign an informed consent to participate in the current study and that they would not participate in other clinical trials within 30 days from the last administration of the study drugs.

- severe covid-19 patients who met one of the following conditions: (1) respiratory rate (rr) ≥ 30 times / min; (2) sao2 / spo2 ≤ 93% in resting state; (3) arterial partial pressure of oxygen (pao2) / concentration of oxygen (fio2) ≤ 300 mmhg - critical covid-19 patients with one of the following conditions: (1) respiratory failure and need mechanical ventilation; (2) shock; (3) other organ failure combined with icu treatment; severe liver disease (such as child pugh score ≥ c, ast > 5 times upper limit); - patients with contraindications specified for sofosbuvir- ledipasvir; the pregnancy test of female subjects during the screening period was positive, the researchers judged that the patient was not suitable to participate in this clinical study due to devastating co-morbid diseases (e.g. de-compensated liver disease, congested heart failure, chronic kidney disease, malignant or hematological disease under therapy or 3 months ago) and patients received antiviral eradication therapy for hepatitis c or b viruses within the previous 6 months. - patients with chloroquine contra-indications: qtc > 500 m/sec, myasthenia gravis, porphyria, retinal pathology, epilepsy, g6pd deficiency, allergy to 4-aminoquinolone, chronic heart, kidney or liver disease, and arrhythmias. - any patient demonstrates worsening of symptoms, radiological progression with virologically persistence within at least 5 days of the therapeutic evaluation period of the study after exclusion of cytokine storm was considered as a clinical failure and was shifted to the other management protocol. - treatment was terminated at any time by a multidisciplinary team if a serious side effect occurred, which was attributed to the medications used ,e.g. cardiac arrhythmia, deteriorated liver or kidney function or unfortunately patient died .

2

Almaza Military Fever Hospital

18

75

Egypt

Moderate disease at enrollment

3: Moderate disease at enrollment

250

28 days in hospital mortality;Therapeutic success (cured)

None

Phase 3

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