Clinical trial: Evaluation of Humoral Immunity Following COVID-19 in Pregnancy (NCT04568044)

Eligibility criteria:
Inclusion Criteria:

          1. Group A: Mild to moderate COVID-19 (non-pregnant)

             • Current male or female COVID-19 infected (age 18-60 years old) with mild to moderate
             illness

          2. Group B: Severe to critical COVID-19 (non-pregnant)

             • Current male or female COVID-19 infected (age 18-60 years old) with severe to
             critical illness

          3. Group C: Controls (non-pregnant)

             • Male of female uninfected (age 18-60 years old) who have no history of COVID-19
             symptoms or illness

          4. Group D: Pregnant or postnatal with COVID-19

               -  Current pregnant or postnatal COVID-19 infected (age 18-50 years old)

               -  Pregnant or postnatal (within 6 weeks since birth) who were diagnosed with
                  COVID-19 less than 4 months previously (age 18-50 years old)

               -  Singleton pregnancy

          5. Group E: Pregnant or postnatal with influenza

               -  Current pregnant or postnatal influenza infected (age 18-50 years old)

               -  Pregnant or postnatal (within 6 weeks since birth) who were diagnosed with
                  influenza less than 4 months previously (age 18-50 years old)

               -  Singleton pregnancy

          6. Group F: Pregnant and have received the influenza vaccine

               -  Current pregnant who has received the influenza vaccine (age 18-50 years old)

               -  Singleton pregnancy

        Exclusion Criteria:

          1. Group A, Group B and Group C:

               -  Patients unable to understand verbal or written information in English, regarding
                  the study. Lack of capacity to consent at the point of recruitment

               -  Pregnant

               -  Participants who have previously been part of any SARS-CoV-2 vaccine trial

               -  Evidence of HIV infection

               -  Participants on medication that may significantly affect their immune system such
                  as chemotherapy drugs

               -  Vulnerable patients with known safe-guarding issues

               -  Pregnant with more than one baby

          2. Group D, E and F:

               -  Patients unable to understand verbal or written information in English, regarding
                  the study.

               -  Lack of capacity to consent at the point of recruitment

               -  Participants who have previously been part of any SARS-CoV-2 vaccine trial

               -  Evidence of HIV infection

               -  Participants on medication that may significantly affect their immune system such
                  as chemotherapy drugs other than steroids, which have been given for fetal lung
                  maturity

               -  Vulnerable patients with known safe-guarding issues

               -  Pregnant with more than one baby
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years

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? Contradiction