Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT04941703
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years
2. Currently hospitalized or in an emergency department with anticipated hospitalization.
3. Symptoms of acute respiratory infection, defined as one or more of the following:
1. Cough
2. Fever (\> 37.5° C / 99.5° F)
3. Shortness of breath (operationalized as any of the following: subjective shortness of breath reported by patient or surrogate; tachypnea with respiratory rate ≥22 /minute; hypoxemia, defined as SpO2 \<92% on room air, new receipt of supplemental oxygen to maintain SpO2 ≥92%, or increased supplemental oxygen to maintain SpO2 ≥92% for a patient on chronic oxygen therapy).
4. Sore throat
5. Anosmia
4. Laboratory-confirmed SARS (Severe acute respiratory syndrome-Coronavirus 2 (SARS CoV-2) infection within 10 days prior to randomization
5. Ability to manage own stool care
Exclusion Criteria:
1. Prisoner
2. Pregnancy
3. Breast feeding
4. Current infectious or noninfectious diarrheal illness
5. Unable to randomize within 21 days after onset of acute respiratory infection symptoms
6. Unable to randomize after hospital arrival
7. Colonic obstruction
8. Unresolved hypovolemia
9. CrCl \<30ml/min
10. Hypermagnesemia
11. Diagnosis of Long QT syndrome
12. Known allergy to magnesium citrate or probiotic
13. Unresolved electrolyte imbalance such as hypokalemia or hypocalcemia. The patient can be enrolled if electrolytes are corrected and sustained.
14. Receipt of \>1 dose of magnesium citrate or any other colonic cleanser in the 7 days prior to enrollment
15. Inability to receive enteral medications
16. Refusal or inability to be contacted on Day 15 for clinical outcome assessment if discharged prior to Day 15
17. Concurrent medical illness that interferes with clinical assessment Previous enrollment in this trial
18. The treating clinical team does not believe equipoise exists regarding the use of magnesium citrate plus a probiotic for the treatment of this patient.
19. Participating in any other COVID-19 therapeutic trial
20. Allergic to soy.
21. Lactose intolerant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT04941703
Study Brief:
Protocol Section:
NCT04941703