Investigation of Choice Alteration of the Gut Metagenome on COVID-19 Severity
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- COVID Ordinal Outcome Scale
研究概览
简要总结
We are conducting an investigator-initiated, single center, blinded, placebo-controlled, randomized clinical trial evaluating magnesium citrate combined with a probiotic for the treatment of adults hospitalized with COVID-19.
详细描述
We are conducting an investigator-initiated, single center, blinded, placebo-controlled, randomized clinical trial evaluating magnesium citrate combined with a probiotic for the treatment of adults hospitalized with COVID-19. Patients, treating clinicians, and study personnel will all be blinded to study group assignment.
This research study is being done to determine if taking oral magnesium citrate and a probiotic will improve the outcome of adults hospitalized with COVID-19. In this study, half of the participants will receive magnesium citrate plus a probiotic and half will receive a placebo randomized 1:1. You will be placed in one of these 2 groups randomly, like the flip of a coin. The investigational arm will receive one 10 oz. bottle of magnesium citrate to drink once and 2 oral probiotic capsules to be taken twice a day for 6 days. We will also collect a blood sample on Day 1 and Day 7 for CD4+ and CD8+ evaluation and will be collecting data on each participants COVID-19 infection progression during hospitalization.
Assessments for this study will be done on day 7 and day 29 if the participant is still hospitalized at those time points. If they have been discharged from the hospital before these assessments, we will do these by phone. Each participant will also be contacted at 3 months to assess how they are doing. There will be no compensation for taking part in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Currently hospitalized or in an emergency department with anticipated hospitalization.
- •Symptoms of acute respiratory infection, defined as one or more of the following:
- •Fever (> 37.5° C / 99.5° F)
- •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).
- •Sore throat
- •Laboratory-confirmed SARS (Severe acute respiratory syndrome-Coronavirus 2 (SARS CoV-2) infection within 10 days prior to randomization
- •Ability to manage own stool care
排除标准
- •Breast feeding
- •Current infectious or noninfectious diarrheal illness
- •Unable to randomize within 21 days after onset of acute respiratory infection symptoms
- •Unable to randomize after hospital arrival
- •Colonic obstruction
- •Unresolved hypovolemia
- •CrCl <30ml/min
- •Hypermagnesemia
- •Diagnosis of Long QT syndrome
- •Known allergy to magnesium citrate or probiotic
- •Unresolved electrolyte imbalance such as hypokalemia or hypocalcemia. The patient can be enrolled if electrolytes are corrected and sustained.
- •Receipt of >1 dose of magnesium citrate or any other colonic cleanser in the 7 days prior to enrollment
- •Inability to receive enteral medications
- •Refusal or inability to be contacted on Day 15 for clinical outcome assessment if discharged prior to Day 15
- •Concurrent medical illness that interferes with clinical assessment Previous enrollment in this trial
- •The treating clinical team does not believe equipoise exists regarding the use of magnesium citrate plus a probiotic for the treatment of this patient.
- •Participating in any other COVID-19 therapeutic trial
- •Allergic to soy.
- •Lactose intolerant.
研究组 & 干预措施
Magnesium Citrate plus a Probiotic Arm:
Participants assigned to the magnesium citrate plus a probiotic arm will receive 1 bottle of magnesium citrate 296 mL PO once to be taken within a 4-hour period, (about 10 oz.). Because magnesium citrate remains within the intestinal lumen, a second bottle can be provided if there is limited bowel movement. Patients will be asked to take 2 capsules of probiotics twice daily for six days or until discharge, whichever is earlier.
干预措施: Magnesium Citrate plus probiotic (Drug)
Placebo
Participants randomized to the placebo arm will receive matching placebo 296 mL PO once to be taken within a 4-hour period, (about 10 oz.) and 2 cellulose capsules twice daily for six days or until discharge, whichever is earlier. The placebo will be flavored to match the taste of the interventional arm.
干预措施: Magnesium Citrate plus probiotic (Drug)
结局指标
主要结局
COVID Ordinal Outcome Scale
时间窗: Baseline through Day 7 after completion of therapy
Outcome measured clinical status of the participant defined by the COVID Ordinal Outcome Scale on Day 7: 0 = Uninfected, no viral RNA detected 1. = Asymptomatic, viral RNA detected 2. = Symptomatic, independent 3. = Symptomatic, assistance needed 4. = Hospitalized, no oxygen needed 5. = Hospitalized, oxygen by mask or nasal prongs 6. = Hospitalized, oxygen by NIV or high flow 7. = Intubation and mechanical ventilation, pO2/FiO2 ≥150 or SpO2/FiO2 ≥200 8. = Mechanical ventilation, pO2/FiO2 \<150 (SpO2/FiO2 \<200) or vasopressors 9. = Mechanical ventilation, pO2/FiO2 \<150 and vasopressors, dialysis or ECMO 10. = Dead
次要结局
- Change in Oxygen Requirements From Baseline to Day 7 by Treatment Group(baseline and 7 days)
研究者
Wonder Drake
Wonder Drake, MD
Vanderbilt University Medical Center