Clinical trial: Hydroxychloroquine and Lopinavir/ Ritonavir to Improve the Health of People With COVID-19: "The Hope Coalition - 1" (NCT04403100)

Eligibility criteria:
Inclusion Criteria:

        Patients with RT-PCR diagnosis of COVID-19 or a clinical condition compatible with COVID-19
        and respiratory symptoms, presenting:

        A. Persistent dry cough associated with axillary temperature > 37.7 Celsius;

        OR

        B. Recent onset of Flu-like Respiratory Symptoms associated with dry cough

        OR

        C. Tomographic image compatible with COVID 19 infection;

        2. Men and women aged > 50 years OR: Patients over 18 years of age with at least one of the
        following criteria

          -  Diabetes requiring oral medication or insulin.

          -  Arterial hypertension requiring at least 01 oral medication for treatment

          -  Known cardiovascular diseases (CHF of any etiology, documented Coronary Artery
             Disease, Clinically overt heart disease)

          -  Symptomatic chronic lung disease and/ or medically controlled

          -  Patients with a history of transplantation

          -  Patient with stage IV chronic kidney disease or on dialysis.

          -  Patients on current Immunosuppression and/or using corticosteroid therapy (equivalent
             to at least 10 mg of oral prednisone per day)

          -  Willingness to comply with study related procedures

             3. Ability to provide informed consent before any protocol-related procedures.

        Exclusion Criteria:

          1. RT-PCR exam for COVID-19 negative during the screening visit.

          2. Patients with an acute respiratory condition compatible with COVID-19 being
             hospitalized;

          3. Patients with an acute respiratory condition and with moderate to high probability of
             not being a COVID infection 19;

          4. Dyspnea secondary to other acute and chronic respiratory causes or infections (eg,
             decompensated Chronic Obstructive Pulmonary Disease, acute bronchitis, pneumonia,
             primary pulmonary arterial hypertension);

          5. Severe respiratory clinical condition, presenting at least ONE of the criteria below:

               1. Respiratory Rate> 28 / min;

               2. Arterial Oxygen Saturation < 92% with nasal oxygen therapy at 10 l/ min;

               3. PaO2 / FIO2 <300 mmHg

        4. History of Cardiac Arrhythmia or Long QT Syndrome; 5. Use of Medications that are known
        to prolong QTc: Citalopram, Venlafaxine, Bupropion and with no possibility of suspension
        during the period of investigational medical product administration. 6. Inability to take
        oral medications; 7. Patients on continuous use of Amiodarone and / or PGE5 Inhibitors (Ex
        .: Sildenafil and similar). 8. Use of Digoxin, Cyclosporine, Cimetidine, Tamoxifen. 9. Use
        of anticonvulsants, antifungals, immunosuppressants other than corticotherapy. 10. Use of
        Hydroxychloroquine for other indications 11. Use of chemoprophylaxis for malaria. 12.
        Psoriasis in a form other than cutaneous 13. Porphyria 14. Use of protease inhibitors,
        ritonavir or Cobicistat 15. Clinical history of Liver Cirrhosis or Child-Pugh C
        classification; 16. Patients with a history of degenerative retinal diseases (patients with
        retinal diseases due to diabetes and hypertension can participate in the research); 17.
        Patient with a clinically relevant history of hearing loss; 18. Patients with known severe
        degenerative neurological diseases and / or severe mental illness; 19. Inability of the
        patient or representative to give consent or adhere to the procedures proposed in the
        protocol; 20. Known hypersensitivity and / or intolerance to Hydroxychloroquine. 21.
        Hypersensitivity and / or intolerance Lopinavir / Ritonavir

        -
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