Study of LAU-7b for the Treatment of Coronavirus Disease 2019 (COVID-19) Disease in Adults

Inclusion Criteria

• •1. Participant exhibited symptoms \[Extension Phase 3 study only: (including at least one lower respiratory symptom such as shortness of breath or dyspnea)\] of COVID-19 disease at screening and/or since the start of their hospitalization (may have included treated symptoms)
• •2. Participant was 18 years and older, of either gender
• •3. Participant must have had at least one of the following factors/co-morbidities:
• •1. Controlled or uncontrolled diabetes
• •2. Pre-existing cardiovascular disease, including hypertension
• •3. Pre-existing respiratory disease such as chronic obstructive pulmonary disease(COPD), asthma, emphysema
• •4. Active \[Extension Phase 3 study only: or a former smoker\] with 20 pack-years of smoking history
• •5. Obesity as depicted by BMI ≥30 kg/m2
• •6. Laboratory tests indicative of a higher risk of COVID-19-related complications, such as troponin \>1.5 the upper limit of normal (ULN), \[Extension Phase 3 study only: D-dimer \>3.0 ULN\] and/or C reactive protein (CRP) \>1.5 ULN
• •7. Aged 70 years and older who, based on the judgment of the investigator, was at a higher risk of developing complications
• •4. Participant had a documented positive test for the SARS-CoV-2 virus \[Pilot Phase 2 study only: or was suspected to be positive and with a test result pending\]. \[Extension Phase 3 study only: Co-infection with other viral respiratory infections was allowed and had to be documented in medical history\]
• •5. Participant was under observation by, or admitted to, a controlled facility or hospital \[Extension Phase 3 study only: for no more than 48 hours (72 hours from amendment 3 onwards) before screening, including any prior stay in another hospital\] to receive standard of care (SoC) for COVID-19 disease
• •6. \[Pilot Phase 2 study only: Participant's hs was 3, 4, or 5 on the WHO ordinal scale and not previously a "6"\] \[Extension Phase 3 study only: 3 or 4 on the World Health Organization (WHO) ordinal scale and not previously a "5 or a 6"\]
• •7. If female, participant was either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who were capable of conception had to be practicing a highly effective method of birth control (acceptable methods included intrauterine device, complete abstinence, spermicide + barrier, male partner surgical sterilization, or hormonal contraception) during the study and through 30 days after the last dose of the study medication. Periodical abstinence was not classified as an effective method of birth control. A pregnancy test had to be negative at the Screening Visit
• •8. Participant had the ability to understand and give informed consent, which could have been verbal with a witness, according to local requirements
• •9. Participant was deemed capable of adequate compliance including attending scheduled visits for the duration of the study
• •10. Participant was able to swallow the study drug capsules