Clinical trial: COVID-19 Long-Haulers Study (NCT04678830)

Eligibility criteria:
Inclusion Criteria:

          1. Male or female adult ≥ 18 years of age at time of enrollment.

          2. Prior confirmed COVID-19 diagnosis by standard RT-PCR assay or equivalent testing

          3. Clinical Symptom Score of ≥6 AND at least two symptoms of moderate or higher severity
             as listed below at the time of Screening and currently experiencing two or more of the
             following symptoms consistent with COVID-19 infection for a prolonged period of time
             (>12 weeks).

             Clinical symptoms include the following:

               -  Respiratory symptoms such as cough, sore throat, stuffy or runny nose, shortness
                  of breath (difficulty breathing), tightness of chest.

               -  Neurological symptoms such as difficulty in concentration (brain fog), sleep
                  disturbance/insomnia, headache, dizziness, anxiety, tingling or numbness, loss of
                  sense of smell or taste.

               -  Cardiovascular and Gastrointestinal symptoms such as feeling of fast heartbeat,
                  nausea, vomiting, diarrhea.

               -  Musculoskeletal symptoms such as muscle aches/cramps, muscle weakness, joint
                  pain/swelling.

               -  General immune response symptoms such as fatigue (low energy or tiredness),
                  chills or shivering, feeling hot or feverish, or exertional malaise (feeling of
                  discomfort, illness, or lack of well-being after physical activity or mental
                  stress).

             Note: Clinical Symptom Score is obtained from the patient diary (refer to Appendix 1
             for scoring instructions).

          4. Electrocardiogram (ECG) with no clinically significant findings as assessed by the
             Investigator.

             Note: Below are the examples of clinically significant and non-clinically significant
             ECG abnormalities:

               -  ECG findings indicative of acute myocardial infarction or acute ischemic changes
                  would be considered clinically significant abnormalities.

               -  ECG finding such as atrial fibrillation, atrial flutter, paced rhythms in
                  individuals who have undergone permanent pacemaker placement, evidence of prior
                  infarction, unchanged stable conduction abnormalities e.g. right bundle branch
                  block, or any other finding which does not significantly impact mortality would
                  be considered non-clinically significant findings and subjects with these
                  abnormal findings would be allowed to enroll in the study.

          5. Subject (or legally authorized representative) provides written informed consent prior
             to initiation of any study procedures.

          6. Men and women of childbearing potential and their partner must agree to use two
             medically accepted methods of contraception (e.g., barrier contraceptives [male
             condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives
             [implants, injectables, combination oral contraceptives, transdermal patches, or
             contraceptive rings], or one of the following methods of birth control (intrauterine
             devices, bilateral tubal occlusion, or vasectomy) or must practice complete sexual
             abstinence for the duration of the study (excluding women who are not of childbearing
             potential and men who have been sterilized).

          7. Females of child-bearing potential must have a negative urine pregnancy test at
             Screening Visit and prior to receiving the first dose of study drug; and Male
             participants must agree to use contraception and refrain from donating sperm for at
             least 90 days after the last dose of study intervention.

          8. Subject is willing and able to comply with scheduled visits, drug administration plan,
             laboratory tests, other study procedures and study restrictions

        Exclusion Criteria:

          1. Exhibiting signs of moderate or severe pulmonary disease (such as COPD, asthma, or
             pulmonary fibrosis)

          2. Ongoing requirement of oxygen therapy

          3. Pulse oxygen saturation (SpO2) of <94% on room air at the time of screening

          4. History of splenectomy

          5. Liver cirrhosis or patient showing signs of clinical jaundice at the time of screening

          6. Chronic kidney disease stage 4 or requiring dialysis at the time of screening

          7. NYHA Class III or IV congestive heart failure (CHF)

          8. Exhibiting signs of uncontrolled hypo-or hyper- thyroidism at the time of Screening

          9. Uncontrolled rheumatologic disorders at the time of screening

         10. History of organ transplantation or are candidates for organ transplantation at the
             time of screening

         11. History of Chronic Fatigue Syndrome prior to COVID-19 infection

         12. History of fibromyalgia prior to COVID-19 infection

         13. History of major psychiatric disorder including bipolar disorders, schizophrenia,
             schizoaffective disorder, major depression. Patients with major depression can be
             enrolled if patient has had no episode within the past year or is considered in
             remission or controlled by treatment.

         14. Any malignancy within the past 5 years, excluding successfully treated basal cell
             carcinoma or squamous cell carcinoma without evidence of metastases.

         15. Any other clinically significant serious systemic diseases which would interfere with
             study conduct or study results interpretation per the Investigator.

         16. Treatment with immunosuppressive or immunomodulatory medications within 5 half-lives
             prior to screening. Patients on replacement therapy for adrenal insufficiency will be
             allowed. Patients on stable (> 3 months) low dose corticosteroid ≤ 5 mg Prednisone
             will be allowed.

         17. History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to leronlimab (PRO 140) are not eligible

         18. Ongoing use of CCR5 antagonist

         19. Inability to provide informed consent or to comply with test requirements

         20. Consideration by the investigator, for safety reasons, that the subject is an
             unsuitable candidate to receive study treatment

         21. Pregnancy or breast feeding

         22. Participating in another study for an investigational treatment
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? 0