A Phase III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Safety and Efficacy of AZD7442 for the Treatment of COVID-19 in Non-hospitalized Adults

JRCT ID: jRCT2031200368

Registered date:19/02/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 28/01/2021
• Target sample size: 20
• Countries of recruitment: Germany,Japan,Italy,Japan,Hungary,Japan,Russia,Japan,Spain,Japan,UK,Japan,USA,Japan,Mexico,Japan,Peru Rep,Japan,Poland Rep,Japan,Czech Rep,Japan
• Study type: Interventional

Intervention(s)

Receive one single 600 mg dose of AZD7442(administered as a 3 mL IM injection containing 300 mg AZD8895 and a 3 mL IM injection
containing 300 mg AZD1061) or saline placebo (administered as 2 separate 3 mL IM injections)

Outcome(s)

Primary Outcome

A composite of either severe COVID-19 or death from any cause through Day 29. [ Time Frame: Through Day 29 ]
To estimate the efficacy of AZD7442 in the prevention of the composite endpoint of either severe COVID-19 or death from any cause through study Day 29.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Participant has a documented laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular test (antigen or nucleic acid) from any respiratory tract specimen (eg, oropharyngeal, NP, or nasal swab, or saliva) collected less than or equal to 3 days prior to Day 1.

2. WHO Clinical Progression Scale score over 0 and less than 4.

3. Participant must be dosed with IMP no more than 7 days from self-reported onset of COVID-19-related symptoms (mild to moderate COVID-19) or measured fever, defined as the self-reported date of first reported sign/symptom.

4. One or more of the following signs/symptoms must be present within 24 hours prior to Day1: Cough, Sore throat, Shortness of breath or difficulty breathing at rest or with activity, Body pain or muscle pain/aches, Fatigue, Headache, Chills, Nasal obstruction or congestion, Nasal discharge, Nausea or vomiting, Diarrhea, New loss of taste or smell.

5. Oxygenation saturation of over or equal to 92% obtained at rest by study staff within 24 hours prior to Day 1 (unless participant regularly receives chronic supplementary oxygen for an underlying lung condition).

6. Participant agrees not to participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until reaching hospitalization or 28 days after entry into the study (whichever is earliest).

7. Participant must be over or equal to 18 years of age, provide informed consent and is able to comply with study requirements/procedures."

Exclude criteria

1. History or current hospitalization for COVID-19.
2. Need for hospitalization/immediate medical attention in a clinic/emergency room service
3. Previous adverse reaction to any monoclonal antibodies or known allergy to components of the IMP or placebo.
4. Receipt of any investigational or licensed vaccine for prevention of COVID-19 at any time prior to entry into this study.
5. Requirement or anticipated impending need for mechanical ventilation.
6. Any significant disease, disorder or finding that may increase risk to the participant that might affect his/her ability to participate in this study.
7. Received convalescent COVID-19 plasma treatment any time prior to entry into this study.
8. Pregnant or breastfeeding women.
9. Receipt of any IMP in the previous 90 days or 5 half lives (whichever is longer), or expected receipt of IMP during the study follow-up period, or concurrent participation in another interventional study."

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT04723394