Clinical trial: A Dose Finding, Efficacy and Safety Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19 (NCT04828161)

Eligibility criteria:
Inclusion Criteria:

          1. Men or women ≥ 18 years of age on the day of inclusion (no upper limit).

          2. Presence of two or more COVID-19 symptoms and onset within 7 days prior to dosing:
             Feeling hot or feverish, cough, sore throat, low energy or tiredness, headache, muscle
             or body aches, chills or shivering, and shortness of breath.

          3. Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing (rapid
             antigen test).

          4. Understand and agree to comply with the planned study procedures.

          5. The patient or legally authorized representative give signed informed consent.

        Exclusion Criteria:

          1. Requiring hospitalization at time of screening, or at time of study drug
             administration.

          2. Oxygen saturation (SpO2) ≤ 93% on room air at sea level or ratio of arterial oxygen
             partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2) < 300,
             respiratory rate ≥ 30 per minute, and heart rate ≥ 125 per minute.

          3. Known allergies to any of the components used in the formulation of the ensovibep or
             placebo.

          4. Suspected or proven serious, active bacterial, fungal, viral, or other infection
             (besides SARS-CoV-2) that in the opinion of the investigator could constitute a risk
             when taking intervention.

          5. Any serious concomitant systemic disease, condition, or disorder that, in the opinion
             of the investigator, should preclude participation in this study.

          6. Any co-morbidity requiring surgery within 7 days of dosing, or that is considered
             life-threatening within 29 days of dosing.

          7. Prior or concurrent use of any medication for treatment of COVID-19, including
             antiviral agents, convalescent serum, or anti-viral antibodies. Purely symptomatic
             therapies (e.g., over-the-counter [OTC] cough medications, acetaminophen, and
             nonsteroidal anti-inflammatories [NSAIDs]) are permitted. Prior vaccination for
             COVID-19 is permitted.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Entailment