Clinical study of APRG 64 in mild to moderate COVID patients

Phase 2

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: B342- Coronavirus infection, unspecified

• Registration Number: CTRI/2022/02/040055
• Lead Sponsor: APRG Co Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Male or female between 20 to 65 years (both inclusive) of age at the time of enrolment.

2.Subjects or Legally Acceptable Representative (LAR) who have signed the written informed consent form approved by Ethics Committee after understanding the explanations regarding the study.

3.Confirmed with mild to moderate COVID-19 symptoms through RT-PCR test within 48 hours at the time of screening under any of the following:

A. Mild: Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging.

B. Moderate: Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have an oxygen saturation (SpO2) �94% on room air at sea level.

4.Willing to be hospitalized for the treatment duration (i.e., at least 7 days).

5.Develops or presents with one or more of the following symptoms within 5 days prior to IP treatment:

a. Fever

b. Cough

c. Dyspnea

d. Chills

e. Myalgia

f. Headache

g. Sore throat

h. Loss of smell/taste

i. Stuffy nose

j. Runny nose

k. Fatigue

l. Nausea or vomiting

m. Diarrhea

n. Phlegm

6.Able to comply with the requirements and process in the clinical study.

7.Negative to urine pregnancy test during screening (Women of childbearing potential).

Exclusion Criteria

1.Known hypersensitivity to APRG64, or any of its constituents and lactate.

2.Suspected active bacterial, fungal, viral, or other respiratory infections (besides COVID-19) (Ex: Tuberculosis, pneumonia etc.,).

3.Known history of Tuberculosis.

4.Presenting with Severe symptoms:

a. SpO2 <94% in room condition, PaO2/FiO2 <300 mmHg, Respiratory frequency >30 times/min

b. Requiring High Flow Oxygen, Extracorporeal membrane Oxygenation (ECMO), Continuous Renal Replacement therapy (CRRT).

5.Admitted in Intensive care unit (ICU) at screening or at randomization.

6.Use of immunosuppressor or immunomodulatory drugs within the past 3 months and patients with autoimmune disease.

7.Use of Corticosteroids and antiviral drugs within 6 weeks before screening.

8.Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 5 x upper limit of normal (ULN) at screening.

9.Absolute neutrophil count (ANC) < 1000/�µL at screening.

10.Platelet count < 50,000/ �µL at screening.

11.Serum creatinine > 2 mg/dL ( > 176.8 �¼mol/L) or estimated creatinine clearance < 30 ml/min measured or calculated by Cockroft Gault equation.

12.History of major active or chronic unstable psychiatric illness (e.g., bipolar disorder, obsessive compulsive disorder, and schizophrenia)

13.Any history or presence of conditions precluding ingestion or absorption of the investigational product, inflammatory bowel disease, short bowel syndrome, or other major gastrointestinal disease.

14.Subjects with conditions that affect the study in the opinion of the treating physician (Ex: severe acute respiratory distress syndrome, septicemia).

15.Participated in another clinical trial within 1 month before screening.

16.Pregnant or breastfeeding woman.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ââ?¬Â¢Clinical recovery time: Time taken for clinical recovery of subjective symptoms from baseline to EOT. <br/ ><br>The first day that all symptoms reached ââ?¬Ë?none/not at allââ?¬â?¢ or ââ?¬Ë?weak/a little bitââ?¬â?¢ will be defined as the day of clinical recovery. A modified Flu-PRO questionnaire will be used to analyze the clinical recovery. Patients will rate the extent to which they have experienced symptoms during past 24 hours, using a 5-point severity scale ranging from ââ?¬Ë?not at allââ?¬â?¢ (0) to ââ?¬Ë?very muchââ?¬â?¢ (4). <br/ ><br>ââ?¬Â¢Proportion of subjects who died or had Oxygen therapy (new high flow oxygen, except for nasal prong or facial mask), mechanical ventilation (new NIV (non-invasive mechanical ventilation), MV (invasive mechanical ventilation)) or ECMO) during study duration.Timepoint: baseline to EOT