This study aims to assess the efficacy of the efficacy and safety of investigational drug (NanoS) in patients with mild to moderate COVID-19 at high risk for progression to severe COVID-19, including death.
We conducted a prospective randomized double-blind clinical trial over five months to determine the efficacy of NanoS compared to placebo. The effectiveness of treatment was measured by the significant decline in the number of cases of covid-19 infection and/or a decrease in the viral load determined by SARS-CoV-2 cycle threshold (Ct) value using RT-PCRs test.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
116
orally, during 5 day
Agili Faida
Tunis, Tunisia
Clinical evolution
The evolution clinical state of evaluated patient clinical state after 14 days since the beginning of the disease is made with " a 8-point ordinal scale " (WHO Rd Blue print novel Coronavirus / COVID-19 Therapeutic Trial Synopsis / 18 February 2020)
Time frame: 14DAY
Disappearance of clinical signs
Disappearance of clinical signs (functional and physical) reported and confirmed at the study inclusion visit (Visit 1). The deadline of disappearance: \- Less than or equal to 3 days
Time frame: 3 days
Viral load Ct value
Evaluate the significative decrease of viral load between DAY 0 and DAY 6, and between DAY6 and DAY14 by the variation of CtT values.
Time frame: admission ,DAY6, DAY14
Negativation of the RT- PCR
Negativation of the RT- PCR after 14 days since the beginning of the disease. of the randomization
Time frame: DAY 14
Tolerance
Évaluate the tolerance of the study product (Nano-S1) versus placebo on the occurrence of adverse events
Time frame: DAY 14, DAY 30
Systemic passage
6\. Evaluate the systemic passage of the product of the study by the assay in the blood on J1 (before taking PI ID), on J6 (on the last day) and on DAY 30 in the two study groups.
Time frame: DAY 30
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