Trial Outcomes & Findings for PK and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the US (NCT NCT04582266)

Last Updated: 2023-06-09

Results Overview

AUC calculated using non-compartmental methods with linear up-log down trapezoidal rule (Phoenix WinNonlin v 8.3, Certara®). Intensive PK sampling occurred once, on the day of the 3rd, 4th, or 5th infusion.

Recruitment status

COMPLETED

Target enrollment

54 participants

Primary outcome timeframe

At 3rd, 4th, or 5th infusion. Collection timepoints included: pre-dose, end of infusion (EOI), EOI + 0.75 hours, EOI + 1.5 hours, EOI + 3 hours, EOI + 5 hours, EOI + 7 hours, EOI + 23 hours.

Results posted on

2023-06-09

Participant Flow

Recruitment methods for this study relied on identification of pregnant and non-pregnant women hospitalized for coronavirus disease of 2019 (COVID-19) in a facility that is affiliated with an IMPAACT clinical research site and who recently initiated treatment with remdesivir (RDV) or who may require treatment with RDV. Enrollment occurred between March 31, 2021 and December 29, 2021 across ten sites in the United States.

Participant milestones

Participant milestones
Measure	Arm 1 Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.	Arm 2 Non-pregnant women of childbearing potential hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Overall Study STARTED	26	28
Overall Study Received RDV	25	28
Overall Study COMPLETED	17	23
Overall Study NOT COMPLETED	9	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1 Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.	Arm 2 Non-pregnant women of childbearing potential hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Overall Study Lost to Follow-up	7	5
Overall Study Withdrawal by Subject	1	0
Overall Study Logistical and Personnel Constraints at Time of Infusion	1	0

Baseline Characteristics

PK and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the US

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=25 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.	Arm 2 n=28 Participants Non-pregnant women of childbearing potential hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.	Total n=53 Participants Total of all reporting groups
Age, Continuous	32.2 years STANDARD_DEVIATION 6.4 • n=5 Participants	35.3 years STANDARD_DEVIATION 7.4 • n=7 Participants	33.8 years STANDARD_DEVIATION 7.0 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	17 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	16 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	28 participants n=7 Participants	53 participants n=5 Participants

PRIMARY outcome

Timeframe: At 3rd, 4th, or 5th infusion. Collection timepoints included: pre-dose, end of infusion (EOI), EOI + 0.75 hours, EOI + 1.5 hours, EOI + 3 hours, EOI + 5 hours, EOI + 7 hours, EOI + 23 hours.

Population: Arm 1 women who met the following minimum sampling requirements: (1) at least 3 out of 4 of the end of infusion (EOI) through 3 hours post-end-of-infusion (post-EOI) intensive PK samples AND (2) either the 5 hours post-EOI or the 7 hours post-EOI intensive PK sample AND (3) either the pre-dose or 23-hour post-EOI intensive PK sample, had at least two drug concentrations greater than the lower limit of quantification, and had an available RDV AUC measurement.

Outcome measures

Outcome measures
Measure	Arm 1 n=18 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
PK Outcome: Geometric Mean Area Under the Plasma Concentration-time Curve (AUC) of Remdesivir (RDV) in Arm 1	1246.57 h*ng/mL Interval 915.71 to 1696.99

PRIMARY outcome

t1/2 calculated using non-compartmental methods with linear up-log down trapezoidal rule (Phoenix WinNonlin v 8.3, Certara®). Intensive PK sampling occurred once, on the day of the 3rd, 4th, or 5th infusion.

Outcome measures

Outcome measures
Measure	Arm 1 n=17 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
PK Outcome: Geometric Mean Half-life (t1/2) of Remdesivir (RDV) in Arm 1	1.01 hours Interval 0.87 to 1.17

PRIMARY outcome

GS-441524 is a metabolite of remdesivir (RDV). Ctrough calculated using non-compartmental methods with linear up-log down trapezoidal rule (Phoenix WinNonlin v 8.3, Certara®). Intensive PK sampling occurred once, on the day of the 3rd, 4th, or 5th infusion.

Outcome measures

Outcome measures
Measure	Arm 1 n=20 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
PK Outcome: Geometric Mean Trough Concentration (Ctrough) of GS-441524 in Arm 1	51.6 ng/mL Interval 44.7 to 59.6

PRIMARY outcome

Timeframe: First infusion through 7 Days post-last infusion

Population: Arm 1 women who receive any amount of RDV and had follow-up through 7 days post-last infusion or a renal adverse event of any grade.

Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. We present the proportion of participants with at least one maternal renal AE through 7 days post last infusion, bounded by an exact 95% confidence interval (CI). Renal AEs were defined using the MedDRA system organ class term "Renal and urinary disorders" and high level grouping term "Renal and urinary tract investigations and urinalyses". The number of RDV infusions varied by participant.

Outcome measures

Outcome measures
Measure	Arm 1 n=23 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Safety Outcome: Proportion of Participants With Maternal Renal Adverse Event (AE) of Any Grade in Arm 1	0 proportion of participants Interval 0.0 to 0.15

PRIMARY outcome

Timeframe: First infusion through 7 Days post-last infusion

Population: Arm 1 women who receive any amount of RDV and had follow-up through 7 days post-last infusion or a hepatic adverse event of any grade.

Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. We present the proportion of participants with at least one maternal hepatic AE through 7 days post last infusion, bounded by an exact 95% confidence interval (CI). Hepatic AEs were defined using the MedDRA system organ class term "Hepatobiliary disorders" and high level grouping term "Hepatobiliary investigations". The number of RDV infusions varied by participant.

Outcome measures

Outcome measures
Measure	Arm 1 n=23 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Safety Outcome: Proportion of Participants With Maternal Hepatic Adverse Event (AE) of Any Grade in Arm 1	0.04 proportion of participants Interval 0.0 to 0.22

PRIMARY outcome

Timeframe: First infusion through 7 Days post-last infusion

Population: Arm 1 women who receive any amount of RDV and had follow-up through 7 days post-last infusion or a hematologic adverse event of any grade.

Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. We present the proportion of participants with at least one maternal hematologic AE through 7 days post last infusion, bounded by an exact 95% confidence interval (CI). Hematologic AEs were defined using the MedDRA system organ class term "Blood and lymphatic system disorders" and high level grouping term "Haematology investigations (incl blood groups)". The number of RDV infusions varied by participant.

Outcome measures

Outcome measures
Measure	Arm 1 n=23 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Safety Outcome: Proportion of Participants With Maternal Hematologic Adverse Event (AE) of Any Grade in Arm 1	0.30 proportion of participants Interval 0.13 to 0.53

PRIMARY outcome

Timeframe: First infusion through 4 Weeks post-last infusion and Delivery

Population: Arm 1 women who receive any amount of RDV and had follow-up through 4 weeks post-last infusion and delivery or at least one maternal grade 3 or higher adverse event.

Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one maternal grade 3 or higher adverse event through 4 weeks post last infusion and delivery, bounded by an exact 95% confidence interval (CI). The number of RDV infusions varied by participant.

Outcome measures

Outcome measures
Measure	Arm 1 n=22 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Safety Outcome: Proportion of Participants With Maternal Grade 3 or Higher Adverse Event (AE) in Arm 1	0.68 proportion of participants Interval 0.45 to 0.86

PRIMARY outcome

Timeframe: First infusion through 4 Weeks post-last infusion and Delivery

Population: Arm 1 women who receive any amount of RDV and had follow-up through 4 weeks post-last infusion and delivery or at least one maternal serious adverse event.

Outcome measures

Outcome measures
Measure	Arm 1 n=18 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Safety Outcome: Proportion of Participants With Serious Adverse Event (AE) in Arm 1	0.33 proportion of participants Interval 0.13 to 0.59

PRIMARY outcome

Timeframe: First infusion through 4 Weeks post-last infusion and Delivery

Population: Arm 1 women who receive any amount of RDV and had follow-up through 4 weeks post-last infusion and delivery or at least one maternal grade 3 or higher adverse event assessed as related to RDV by the CMC.

Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one maternal grade 3 or higher AE assessed as related to RDV by the CMC through 4 weeks post last infusion and delivery, bounded by an exact 95% confidence interval (CI). The number of RDV infusions varied by participant.

Outcome measures

Outcome measures
Measure	Arm 1 n=16 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Safety Outcome: Proportion of Participants With Maternal Grade 3 or Higher Adverse Event (AE) Assessed as Related to Remdesivir (RDV) by the Clinical Management Committee (CMC) in Arm 1	0.00 proportion of participants Interval 0.0 to 0.21

PRIMARY outcome

Timeframe: Delivery

Population: Arm 1 women who receive any amount of RDV and had a delivery visit.

We present the proportion of participants who had a pregnancy loss at delivery, bounded by an exact 95% confidence interval (CI).

Outcome measures

Outcome measures
Measure	Arm 1 n=17 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Safety Outcome: Proportion of Participants With Pregnancy Loss in Arm 1	0.06 proportion of participants Interval 0.0 to 0.29

PRIMARY outcome

Timeframe: Delivery

Population: Arm 1 women who receive any amount of RDV, had a delivery visit, and had a live-born infant.

We present the proportion of participants who had a live infant born with congenital anomalies at delivery, bounded by an exact 95% confidence interval (CI).

Outcome measures

Outcome measures
Measure	Arm 1 n=16 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Safety Outcome: Proportion of Participants With Congenital Anomalies in Arm 1	0.00 proportion of participants Interval 0.0 to 0.21

PRIMARY outcome

Timeframe: Delivery

Population: Arm 1 women who receive any amount of RDV, had a delivery visit, and had a live-born infant.

We present the proportion of participants who had a live preterm birth defined as \< 37 weeks, bounded by an exact 95% confidence interval (CI).

Outcome measures

Outcome measures
Measure	Arm 1 n=16 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Safety Outcome: Proportion of Participants With Preterm Birth, Defined as < 37 Weeks in Arm 1	0.25 proportion of participants Interval 0.07 to 0.52

PRIMARY outcome

Timeframe: Delivery

Population: Arm 1 women who receive any amount of RDV, had a delivery visit, and had a live-born infant.

We present the proportion of participants who had a live preterm birth defined as \< 34 weeks, bounded by an exact 95% confidence interval (CI).

Outcome measures

Outcome measures
Measure	Arm 1 n=16 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Safety Outcome: Proportion of Participants With Preterm Birth, Defined as < 34 Weeks in Arm 1	0.00 proportion of participants Interval 0.0 to 0.21

PRIMARY outcome

Timeframe: Delivery

Population: Arm 1 women who receive any amount of RDV, had a delivery visit, and had a live-born infant.

We present the proportion of participants who a live born infant who was small for gestational age defined as \< 10th percentile, bounded by an exact 95% confidence interval (CI).

Outcome measures

Outcome measures
Measure	Arm 1 n=16 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Safety Outcome: Proportion of Participants With Small for Gestational Age, Defined as < 10th Percentile in Arm 1	0.13 proportion of participants Interval 0.02 to 0.38

PRIMARY outcome

Timeframe: Delivery

Population: Infants born to Arm 1 women, who received any amount of RDV and had a delivery visit, and had available weight measurement.

We present the newborn mean weight among the participants who had live born infant, bounded by a 95% confidence interval (CI) calculated using the t distribution.

Outcome measures

Outcome measures
Measure	Arm 1 n=16 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Safety Outcome: Mean Newborn Birth Weight in Arm 1	3.039 kg Interval 2.766 to 3.313

PRIMARY outcome

Timeframe: Delivery

Population: Infants born to Arm 1 women, who received any amount of RDV and had a delivery visit, and had available length measurement.

We present the newborn mean length among the participants who had a live born infant, bounded by a 95% confidence interval (CI) calculated using the t distribution.

Outcome measures

Outcome measures
Measure	Arm 1 n=8 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Safety Outcome: Mean Newborn Length in Arm 1	44.1 cm Interval 37.1 to 51.1

PRIMARY outcome

Timeframe: Delivery

Population: Infants born to Arm 1 women, who received any amount of RDV and had a delivery visit, and had available head circumference measurement.

We present the newborn mean head circumference among the participants who had a live born infant, bounded by a 95% confidence interval (CI) calculated using the t distribution.

Outcome measures

Outcome measures
Measure	Arm 1 n=8 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Safety Outcome: Mean Newborn Head Circumference in Arm 1	29.9 cm Interval 25.3 to 34.5

SECONDARY outcome

Population: Arm 2 women who met the following minimum sampling requirements: (1) at least 3 out of 4 of the end of infusion (EOI) through 3 hours post-end-of-infusion (post-EOI) intensive PK samples AND (2) either the 5 hours post-EOI or the 7 hours post-EOI intensive PK sample AND (3) either the pre-dose or 23-hour post-EOI intensive PK sample, had at least two drug concentrations greater than the lower limit of quantification, and had an available RDV AUC measurement.

Outcome measures

Outcome measures
Measure	Arm 1 n=17 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
PK Outcome: Geometric Mean Area Under the Plasma Concentration-time Curve (AUC) of Remdesivir (RDV) in Arm 2	1302.75 h*ng/mL Interval 1069.7 to 1586.58

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Arm 1 n=16 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
PK Outcome: Geometric Mean Half-life (t1/2) of Remdesivir (RDV) in Arm 2	1.09 hours Interval 0.94 to 1.27

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Arm 1 n=21 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
PK Outcome: Geometric Mean Trough Concentration (Ctrough) of GS-441524 in Arm 2	57.1 ng/mL Interval 48.7 to 66.9

SECONDARY outcome

Timeframe: First infusion through 7 Days post-last infusion

Population: Arm 2 women who receive any amount of RDV and had follow-up through 7 days post-last infusion or a renal adverse event of any grade.

Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. We present the proportion of participants with at least one renal AE through 7 days post last infusion, bounded by an exact 95% confidence interval (CI). Renal AEs were defined using the MedDRA system organ class term "Renal and urinary disorders" and high level grouping term "Renal and urinary tract investigations and urinalyses". The number of RDV infusions varied by participant.

Outcome measures

Outcome measures
Measure	Arm 1 n=23 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Safety Outcome: Proportion of Participants With Renal Adverse Event (AE) of Any Grade in Arm 2	0.04 proportion of participants Interval 0.0 to 0.22

SECONDARY outcome

Timeframe: First infusion through 7 Days post-last infusion

Population: Arm 2 women who receive any amount of RDV and had follow-up through 7 days post-last infusion or a hepatic adverse event of any grade.

Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. We present the proportion of participants with at least one hepatic AE through 7 days post last infusion, bounded by an exact 95% confidence interval (CI). Hepatic AEs were defined using the MedDRA system organ class term "Hepatobiliary disorders" and high level grouping term "Hepatobiliary investigations". The number of RDV infusions varied by participant.

Outcome measures

Outcome measures
Measure	Arm 1 n=24 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Safety Outcome: Proportion of Participants With Hepatic Adverse Event (AE) of Any Grade in Arm 2	0.04 proportion of participants Interval 0.0 to 0.21

SECONDARY outcome

Timeframe: First infusion through 7 Days post-last infusion

Population: Arm 2 women who receive any amount of RDV and had follow-up through 7 days post-last infusion or a hematologic adverse event of any grade.

Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. We present the proportion of participants with at least one hematologic AE through 7 days post last infusion, bounded by an exact 95% confidence interval (CI). Hematologic AEs were defined using the MedDRA system organ class term "Blood and lymphatic system disorders" and high level grouping term "Haematology investigations (incl blood groups)". The number of RDV infusions varied by participant.

Outcome measures

Outcome measures
Measure	Arm 1 n=23 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Safety Outcome: Proportion of Participants With Hematologic Adverse Event (AE) of Any Grade in Arm 2	0.26 proportion of participants Interval 0.1 to 0.48

SECONDARY outcome

Timeframe: First infusion through 4 Weeks post-last infusion

Population: Arm 2 women who receive any amount of RDV and had follow-up through 4 weeks post-last infusion or at least one grade 3 or higher adverse event.

Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 4 weeks post last infusion, bounded by an exact 95% confidence interval (CI).

Outcome measures

Outcome measures
Measure	Arm 1 n=24 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Safety Outcome: Proportion of Participants With Grade 3 or Higher Adverse Event (AE) in Arm 2	0.54 proportion of participants Interval 0.33 to 0.74

SECONDARY outcome

Timeframe: First infusion through 4 Weeks post-last infusion

Population: Arm 2 women who receive any amount of RDV and had follow-up through 4 weeks post-last infusion or at least one serious adverse event.

Outcome measures

Outcome measures
Measure	Arm 1 n=23 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Safety Outcome: Proportion of Participants With Serious Adverse Event (AE) in Arm 2	0.17 proportion of participants Interval 0.05 to 0.39

SECONDARY outcome

Timeframe: First infusion through 4 Weeks post-last infusion

Population: Arm 2 women who receive any amount of RDV and had follow-up through 4 weeks post-last infusion or at least one grade 3 or higher adverse event assess as related to RDV by the CMC.

Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE as related to RDV by the CMC through 4 weeks post last infusion, bounded by an exact 95% confidence interval (CI). The number of RDV infusions varied by participant.

Outcome measures

Outcome measures
Measure	Arm 1 n=23 Participants Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Safety Outcome: Proportion of Participants With Grade 3 or Higher Adverse Event (AE) Assessed as Related to Remdesivir (RDV) by the Clinical Management Committee (CMC) in Arm 2	0.04 proportion of participants Interval 0.0 to 0.22

OTHER_PRE_SPECIFIED outcome

Timeframe: Delivery

Population: No cord blood was collected.

Ratio of cord blood/maternal plasma is calculated for women in Arm 1 who received RDV within 5 days of delivery only.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Delivery

Population: No cord blood was collected.

GS-441524 is a metabolite of remdesivir (RDV). Ratio of cord blood/maternal plasma is calculated for women in Arm 1 who received RDV within 5 days of delivery only.

Outcome measures

Outcome data not reported

Adverse Events

Arm 1

Serious events: 7 serious events

Other events: 15 other events

Deaths: 0 deaths

Arm 2

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 n=25 participants at risk Pregnant women hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.	Arm 2 n=28 participants at risk Non-pregnant women of childbearing potential hospitalized and receiving RDV for treatment of COVID-19. Remdesivir: RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.
Cardiac disorders Foetal heart rate deceleration abnormality	4.0% 1/25 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.	0.00% 0/28 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.
General disorders Asthenia	4.0% 1/25 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.	0.00% 0/28 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.
Infections and infestations COVID-19 pneumonia	4.0% 1/25 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.	0.00% 0/28 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.
Investigations Haemoglobin decreased	0.00% 0/25 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.	3.6% 1/28 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.
Pregnancy, puerperium and perinatal conditions Foetal death	4.0% 1/25 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.	0.00% 0/28 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.
Pregnancy, puerperium and perinatal conditions Gestational hypertension	4.0% 1/25 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.	0.00% 0/28 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.
Pregnancy, puerperium and perinatal conditions Superimposed pre-eclampsia	4.0% 1/25 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.	0.00% 0/28 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.
Psychiatric disorders Substance-induced psychotic disorder	0.00% 0/25 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.	3.6% 1/28 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	4.0% 1/25 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.	3.6% 1/28 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	4.0% 1/25 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.	3.6% 1/28 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/25 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.	3.6% 1/28 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.
Respiratory, thoracic and mediastinal disorders Respiratory failure	8.0% 2/25 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.	3.6% 1/28 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.
Vascular disorders Hypotension	4.0% 1/25 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.	0.00% 0/28 • Enrolled women in Arm 1 were followed for 4 weeks after the last RDV infusion and at delivery. Enrolled women in Arm 2 were followed for 4 weeks after the last RDV infusion. The definition of adverse event provided in Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) was used in this study. This definition was applied to all participants at the time of the first infusion until four weeks after the last infusion and during the Delivery period for Arm 1 participants, if it occurred after Safety Follow-up period. Any medical conditions that occurred prior to the first infusion were considered pre-existing conditions.

Other adverse events

Additional Information

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