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A Phase 2/3 Randomized and Placebo-Controlled Study of ANA001 in Moderate COVID-19

Alpesh Amin


A Study On:

  • Coronavirus Infection

Status:

  • Open

Eligibility

18 Years and older (Adult, Older Adult)

Interested in joining this trial?

Official Title

A Phase 2/3 Randomized and Placebo-Controlled Study of ANA001 in Moderate COVID-19

Details

Subjects randomized to the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.

Subjects randomized to the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration.


Eligibility

You can join if...

Key Inclusion Criteria:

  1. Provide written informed consent prior to performing study procedures
  2. Hospitalized
  3. Positive for severe acute respiratory syndrome coronavirus 2
  4. Presence of symptoms of lower respiratory tract infection (LRTI) including at least 1 of the following: fever, cough, sore throat, malaise, headache, muscle pain, or more significant lower respiratory tract symptoms, including shortness of breath.
  5. At least 1 of the following: respiratory rate (RR) greater than or equal to 20 breaths per minute, room air oxygen saturation (SpO2) <98%, requirement for supplemental oxygen, heart rate (HR) greater than equal to 90 beats per minute, or temperature >38.3°C
  6. Women of childbearing potential must agree to abstinent or use at least 1 form of contraception not including hormonal contraception from the day of screening through Day 30

Key Exclusion Criteria:

  1. Hospitalized but no longer requires ongoing inpatient care (i.e., discharge is anticipated in less than or equal to 24 hours)
  2. Patient is not anticipated to survive >48 hours OR is under palliative care 2. Respiration Rate greater than or equal to 30 breaths per minute, Heart Rate greater than or equal to 125 beats per minute, or Oxygen Saturation (SpO2) less than equal to 93% on less than or equal to 2 L/min nasal cannula oxygen
  3. Evidence of critical illness, defined by at least 1 of the following:
  4. Respiratory failure requiring at least 1 of the following:

a. Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula

b. Noninvasive positive pressure ventilation (NIPVV), OR

c. Extracorporeal membrane oxygenation (ECMO) or clinical diagnosis of respiratory failure

Get in touch with our study team