Extension Study in a Cohort of Adult Patients With COVID-19 Infection

Number and percentage of patients who developed complications related to post COVID-19 infection

Percentage of patients requiring oxygen therapy

Percentage of patients with complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not).

PaO2/FiO2 (Ratio of partial pressure arterial oxygen and fraction of inspired oxygen) mean, standard deviation.

PaO2/FiO2 ratio to evaluate disease severity and discriminate between 'Moderate' and 'Severe' categories according to FDA guidance.

FEV1 (Forced expiratory volume 1) mean, standard deviation.

Lung difussion testing: mean and standard deviation. Unit of measure: % reference theoretical value

Percentage of patients with alterations in chest radiography

Percentage of patients with electrocardiogram alterations

Percentage of patients with ≥grade 2 alterations in laboratory parameters Grade measured according to NCI-CTCAE v5.0 (National Cancer Institute - Common Terminology Criteria for Adverse Events version 5.0) where Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.

Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL* Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

Percentage of patients in each category of the Modified Medical Research Council (mMRC) dyspnea scale.

The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4:

0, no breathlessness except on strenuous exercise;

• shortness of breath when hurrying on the level or walking up a slight hill;
• walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level;
• stops for breath after walking ∼100 m or after few minutes on the level; and
• too breathless to leave the house, or breathless when dressing or undressing.

FEV1/FVC mean, standard deviation.

FVC mean, standard deviation.

SaO2 (Arterial oxygen saturation) mean, standard deviation. Unit of measure: percentage of oxygen saturation

The Barthel index measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL) i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing.

Percentage of patients at each category according to the score obtained: 0-20: Total dependence; 21-60: Severe dependence; 61-90: Moderate dependence; 91-99: Low dependence; 100: Independence

Percentage of patients requiring hospital readmission

minute walking test mean, standard deviation. Total distance measured in meters (m)

minute walking test mean, standard deviation. Expected distance (the predicted distance that a patient could walk) measured in meters (m)

6 minute walking test mean, standard deviation. Unit of measure: Percentage of predicted distance

6 minute walking test mean, standard deviation. Unit of measure: Number of laps of 60 m