Correlated Drug Terms (3)

---

	Name (Synonyms)	Correlation
drug1463	Melatonin 2mg Wiki	1.00
drug2134	SARS-CoV-2 convalescent plasma Wiki	0.58
drug1853	Placebo oral tablet Wiki	0.19

Correlated MeSH Terms (3)

---

	Name (Synonyms)	Correlation
D007239	Infection NIH	0.06
D045169	Severe Acute Respiratory Syndrome NIH	0.05
D018352	Coronavirus Infections NIH	0.04

Correlated HPO Terms (0)

---

	Name (Synonyms)	Correlation

Primary Outcomes

Description: Cumulative incidence measured as the proportion of subjects who were hospitalized or who died prior to hospitalization

Measure: Cumulative incidence of hospitalization or death prior to hospitalization

Time: Up to day 28

---

Description: Cumulative incidence of treatment-related serious adverse events categorized separately as either severe infusion reactions or Acute Respiratory Distress Syndrome (ARDS) during the study period.

Measure: Cumulative incidence of treatment-related serious adverse events

Time: Up to day 28

---

Description: Cumulative incidence measured as the proportion of subjects experiencing a Grade 3 or higher.

Measure: Cumulative incidence of treatment-related grade 3 or higher adverse events

Time: Up to day 90

---

Secondary Outcomes

Description: Analysis of serum SARS-CoV-2 antibody titers will also primarily be descriptive, comparing the geometric mean titers at day 0, 14, 28 and 90 between the randomized arms and calculating the shift or change in the titer distribution.

Measure: Change in serum SARS-CoV-2 antibody titers

Time: Days 0, 14, 28 and 90

---

Description: Compare the rates and duration of SARS-CoV-2 RNA positivity (by RT-PCR) of nasopharyngeal or oropharyngeal fluid between active and control groups at days 0, 14 and 28

Measure: Time to SARS-CoV-2 Polymerase Chain Reaction (PCR) negativity

Time: Day 0, 14 and 28

---

Other Outcomes

Description: Compare the levels of SARS-CoV-2 RNA between active and control groups at days 0, 14 and 28

Measure: Change in level of SARS-CoV-2 RNA

Time: Day 0, 14 and 28

---

Description: Comparison of participant self-assessed blood oxygen saturation levels (in percentage oxygen) between treatment arms using pulse oximetry from Day 0 to Day 28.

Measure: Change in oxygen saturation levels

Time: Day 0 to Day 28 (where available)

---

Description: Secondary infection will be assessed by measuring the number of individuals that live in the same house as the active arm who became sick by the end of follow-up period.

Measure: Rate of participant-reported secondary infection of housemates

Time: Up to day 90

---

Description: Disease severity measured by time (in days) to admission to the ICU or , invasive mechanical ventilation or time to death.

Measure: Time to ICU admission, invasive mechanical ventilation or death in hospital

Time: Up to day 90

---

Description: Time (in days) to resolution of COVID-19 symptoms will be based on temperature logs and symptom score sheets.

Measure: Time to resolution of COVID-19 symptoms

Time: Up to day 90

---

Description: Assess change in hospitalization rate as measured by number of hospitalizations stratified by age groups <65 and >=65

Measure: Impact of convalescent plasma on outcome as assessed by change in hospitalization rate

Time: Day 0 to Day 90

---

Description: Impact of donor antibody titers (high/low) will be assessed by hospitalization rate as measured by number of hospitalizations.

Measure: Impact of donor antibody titers on hospitalizaton rate of convalescent plasma recipients

Time: Day 0 to Day 90

---

Description: Impact of donor antibody titers (high/low) will be assessed by antibody levels

Measure: Impact of donor antibody titers on antibody levels of convalescent plasma recipients

Time: Day 0 to Day 90

---

Description: Impact of donor antibody titers (high/low) will be assessed by viral positivity rates (number of SARS-CoV-2 positive cases per total cases)

Measure: Impact of donor antibody titers on viral positivity rates of convalescent plasma recipients

Time: Day 0 to Day 90

---