Health TrialsbyHealthPanel

To Evaluate SCTA01 Treatment of High-risk Outpatients With COVID-19

ConditionsCOVID-19SARS-CoV-2
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSinocelltech Ltd.

About this trial

The study is a multicenter, adaptive, randomized, double-blinded and placebo-controlled Phase II/III clinical trial. It will be conducted at selected investigational sites globally. The study is comprised of 2 parts.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or non-pregnant female adults, ≥18 years old of age at the time of randomization;

Participants should have at least one of COVID-19 risk factor;

Participants should have at least 2 COVID-19 related symptoms;

Has symptoms consistent with COVID-19 as determined by the investigator with onset ≤7 days before randomization;

Disqualifiers

Have known allergies to any of the components used in the formulation of the SCTA01/placebo;

Participants with a history of severe anaphylaxis, such as severe anaphylactic reaction, urticaria, and angioedema;

Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300, respiratory rate ≥30 per minute, heart rate ≥125 per minute (FDA);

Require mechanical ventilation or anticipated impending need for mechanical ventilation;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SCTA01

    Drug

    Diluted by 0.9% normal saline，IV

  • Placebo

    Other intervention

    IV

Treatment groups

690 Participants
are divided into 4 treatment groups
Group A: SCTA01 low dose +SOCExperimental treatment 1 intervention
Group B: SCTA01 middle dose+SOCExperimental treatment 1 intervention
Group C: SCTA01 High dose +SOCExperimental treatment 1 intervention
Group D: Placebo+SOCPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants who experience COVID-19 related hospitalization (defined as at least 24 hours of acute care) or death (all cause) up to Day 29.

Time frame
Day 29

Secondary outcomes

1

Time to sustained resolution of all COVID-19-related symptoms

Time frame
Day 29
2

- Change in symptom score (total of ratings)

Time frame
Day 3, 5, 7, 11, 15, 22, and 29
3

Time to symptom improvement;

Time frame
Day 29
4

Proportion of participants admitted to hospital due to COVID-19

Time frame
Day 29

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Sinocelltech Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: