Post-acute COVID-19 patients with respiratory conditions
Conditions
Interventions
Control group:Placebo
Experimental group:TM02
Sponsors
LIGNO BIOTECH SDN BHD
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Written informed consent obtained before the initiation of any trial related procedure 2) Patients with diagnosis of COVID-19 confirmed by reverse-transcriptase-polymerase chain reaction (RT-PCR) or Rapid Test Kit- Antigen Test (RTK-Ag) irrespective of CT value 3) Patients with mild to severe disease or Category 2 to 4 disease. 4) Patients with ongoing respiratory conditions such as persistent cough or breathlessness for at least 3 weeks that is related to COVID-19 infection based on the investigator's clinical assessment. 5) Patients with or without organising pneumonia (HRCT consistent with features of organising pneumonia as determined by multidisciplinary discussion (MDD) between pulmonologist and radiologist) or SpO2 18 7 )Patients with pulmonary embolism (PE) can be enrolled into the study. 8) Patients admitted to the ward with diagnosis of COVID
Exclusion criteria
Exclusion criteria: 1) Patients with known or clinically suspected congestive heart failure, chronic lung disease (interstitial lung disease, chronic obstructive pulmonary disease, bronchial asthma, bronchiectasis), secondary bacteria or fungal infection, active pulmonary tuberculosis, advanced malignancy, obesity hypoventilation syndrome, on immunosuppressive therapy, or with any kidney disorder that may potentially affect the study endpoint. 2) Pregnancy 3) Age1.5x ULN) at Visit 1 indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator 9) Subjects known or suspected of not being able to comply with this trial protocol (e.g., due to alcoholism, drug dependency, psychological disorder, or dementia) 10) Female subjects of childbearing potential not willing to use contraceptive methods as described in Section 5.3.1 11) Male subjects not willing to use contraceptive methods as described in Section 5.3.1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The improvement of quality of life;The improvement in cough severity;mMRC score;Resting SpO2;6-minute walk distance and nadir SpO2;Force vital capacity (FVC);Diffusing capacity (DLCO);Radiologically (CXR and/or CT scan); | — |
Secondary
| Measure | Time frame |
|---|---|
| The effect on inflammatory biomarkers (CRP, ferritin, IL-6, IL-10, TNF levels); | — |
Countries
Malaysia
Contacts
Public ContactWong Chee Kuan
Division of Respiratory Medicine, Department of Medicine, Faculty of Medicine, Universiti Malaya
Outcome results
None listed