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"Efesovir" (FS-1) for COVID-19, Phase 2

ConditionCovid19
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-59
SponsorScientific Center for Anti-infectious Drugs, Kazakhstan

About this trial

Study of the efficacy and safety of the new drug "Efesovir" in comparison with the drug "Remdesivir" in the treatment of patients hospitalized with COVID-19.

The hypothesis of clinical study is the clinical efficacy of new drug "Efesovir" is 10% to 30% higher than of "Remdesivir".

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

polymerase chain reaction (PCR) confirmed coronavirus infection (COVID-19) in hospitalized patients with severe risk factors in age from 18 years to 59 years, of both sexes, irrespective of national or ethnic origin

the duration of the COVID-19 disease is no more than 10 days

informed concent to participate in clinical trials

informed concent to to use reliable contraceptive methods while participating in a clinical trial

Disqualifiers

age less than 18 years old and over 59 years old

pregnancy or breastfeeding

hypersensitivity, allergy, intolerance to iodine, iodine-containing medicines

hypersensitivity to Remdesivir or its components

Trial design

Design model

Parallel

Treatments tested in this trial

  • Efesovir

    Drug

    Antiviral therapy of COVID19 with Efesovir oral solution in dose 0.125 ml / kg two times per day. Duration of treatment is 5 - 10 days, depending on the severity of the disease.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: EfesovirExperimental treatment 1 intervention
Group B: RemdesivirActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical Response Rate

Clinical Response Rate is calculated as the number of trial subjects with effective treatment over the total number of subjects multiplied by 100. It is calculated in each study group. Measured in percents. The outcome is estimated among randomized subjects completed clinical study with the protocol requirements (per protocol population (PPP)). Clinical response is evaluated as effective treatment if: all signs and symptoms of COVID19 are resolved or improved with no worsening or appearance of new signs and symptoms; there is no requirement for additional antiviral of antibacterial therapy; chest roentgenograms (CT scans) are improved. The outcome is assessed in day 21 from the start of Study Drug treatment (visits 13).

Time frame
21 days

Secondary outcomes

1

Early Clinical Response Rate

Early clinical response rate defined as complete resolution or significant improvement of at least 2 of 4 leading baseline signs and symptoms within 72 hours after the start of Study (Referent) Drug treatment. It is estimated in the Intent to Treat (ITT) population. The outcome is measured in percents.

Time frame
72 hours (3 days) of study drug treatment
2

Early Clinical Response Rate in pneumonia

The outcome is estimated in patients with pneumonia due to coronavirus infection (modified ITT population). It is defined as complete resolution or significant improvement of at least 2 of 4 main clinical symptoms of pneumonia (cough, shortness of breath, chest pain, sputum) within 72 hours after the start of Study (or Referent) Drug treatment. The outcome is measured in percents. The percentage of subjects with an early clinical response to pneumonia in the compared groups is statistically estimated.

Time frame
72 hours (3 days) of study drug treatment
3

Percentage of clinically stable patients

Percentage of patients at Day 3 who are clinically stable. Clinical stability defined as: * Blood oxygen saturation \>= 93% * Temperature \<=38.0°C * Heart rate \<=100 beats per minute * Respiratory rate \<=25 per minute * Systolic blood pressure ≥90 mm Hg * Ability to maintain oral intake * Normal mental status (oriented to person, place or time) A patient is considered to be clinically stable if all stability criteria are met. The outcome is assessed in ITT population. The difference between groups in the percentage of clinically stable patients from the total number of study subjects in the group is statistically evaluated.

Time frame
72 hours (3 days) of study drug treatment
4

Survival rate

Percentage of participants surviving at day 21. The indicator is calculated as the number of live subjects at the last visit (day 21) divided by the total number of study subjects in the group multiplied by 100. The outcome is estimated among subjects who completed the study in compliance with the protocol (per protocol population (PPP)).

Time frame
21 days

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Semey Medical University Status unavailable 071407, Semey, East KazakhstanKazakhstanKazakhstan

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Scientific Center for Anti-infectious Drugs, Kazakhstan

Lead sponsor

Source ClinicalTrials.gov

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