Trial Outcomes & Findings for Study of Obeldesivir in Participants With COVID-19 Who Have a High Risk of Developing Serious or Severe Illness (NCT NCT05603143)
NCT ID: NCT05603143
Last Updated: 2024-12-20
Results Overview
COVID-19-related hospitalization was defined as ≥ 24 hours of acute care for a reason related to COVID-19, in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with COVID-19. This included specialized acute medical care units within an assisted living facility or nursing home. This did not include hospitalization for the purposes of public health and/or clinical trial execution. The date and duration of hospital admission, and primary reason for hospitalization (including if the hospitalization was related to COVID-19) were recorded. Percentages were rounded off.
TERMINATED
PHASE3
468 participants
Up to Day 29
2024-12-20
Participant Flow
Participants were enrolled at study sites in the South America, Europe, North America, Africa and Asia.
515 participants were screened.
Participant milestones
| Measure |
Obeldesivir
Participants received obeldesivir 350 mg orally twice daily for 5 days.
|
Placebo
Participants received placebo-to-match obeldesivir orally twice daily for 5 days.
|
|---|---|---|
|
Overall Study
STARTED
|
233
|
235
|
|
Overall Study
COMPLETED
|
224
|
227
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
Reasons for withdrawal
| Measure |
Obeldesivir
Participants received obeldesivir 350 mg orally twice daily for 5 days.
|
Placebo
Participants received placebo-to-match obeldesivir orally twice daily for 5 days.
|
|---|---|---|
|
Overall Study
Withdrew consent
|
6
|
2
|
|
Overall Study
Randomized but never treated
|
0
|
3
|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Investigator's discretion
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
The Safety Analysis Set included all participants who received at least 1 dose of study drug with data available were analyzed. One participant randomized to placebo arm received obeldesivir and was counted in obeldesivir group for the analysis of this baseline measure.
Baseline characteristics by cohort
| Measure |
Obeldesivir
n=233 Participants
Participants received obeldesivir 350 mg orally twice daily for 5 days.
|
Placebo
n=235 Participants
Participants received placebo-to-match obeldesivir orally twice daily for 5 days.
|
Total
n=468 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 14.9 • n=233 Participants
|
53 years
STANDARD_DEVIATION 16.6 • n=235 Participants
|
55 years
STANDARD_DEVIATION 15.8 • n=468 Participants
|
|
Age, Customized
Adults (18 - 64 Years)
|
159 Participants
n=233 Participants
|
173 Participants
n=235 Participants
|
332 Participants
n=468 Participants
|
|
Age, Customized
Geriatrics (65 - 84 Years)
|
71 Participants
n=233 Participants
|
59 Participants
n=235 Participants
|
130 Participants
n=468 Participants
|
|
Age, Customized
Geriatrics (85 Years and Over)
|
3 Participants
n=233 Participants
|
3 Participants
n=235 Participants
|
6 Participants
n=468 Participants
|
|
Sex: Female, Male
Female
|
147 Participants
n=233 Participants
|
117 Participants
n=235 Participants
|
264 Participants
n=468 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=233 Participants
|
118 Participants
n=235 Participants
|
204 Participants
n=468 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
36 Participants
n=233 Participants
|
43 Participants
n=235 Participants
|
79 Participants
n=468 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
197 Participants
n=233 Participants
|
192 Participants
n=235 Participants
|
389 Participants
n=468 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=233 Participants
|
0 Participants
n=235 Participants
|
0 Participants
n=468 Participants
|
|
Race/Ethnicity, Customized
White
|
178 Participants
n=233 Participants
|
168 Participants
n=235 Participants
|
346 Participants
n=468 Participants
|
|
Race/Ethnicity, Customized
Asian
|
24 Participants
n=233 Participants
|
32 Participants
n=235 Participants
|
56 Participants
n=468 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
21 Participants
n=233 Participants
|
19 Participants
n=235 Participants
|
40 Participants
n=468 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
9 Participants
n=233 Participants
|
10 Participants
n=235 Participants
|
19 Participants
n=468 Participants
|
|
Race/Ethnicity, Customized
Other or More Than One Race
|
1 Participants
n=233 Participants
|
4 Participants
n=235 Participants
|
5 Participants
n=468 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=233 Participants
|
2 Participants
n=235 Participants
|
2 Participants
n=468 Participants
|
|
Region of Enrollment
Romania
|
29 Participants
n=233 Participants
|
24 Participants
n=235 Participants
|
53 Participants
n=468 Participants
|
|
Region of Enrollment
Singapore
|
1 Participants
n=233 Participants
|
0 Participants
n=235 Participants
|
1 Participants
n=468 Participants
|
|
Region of Enrollment
Hungary
|
0 Participants
n=233 Participants
|
1 Participants
n=235 Participants
|
1 Participants
n=468 Participants
|
|
Region of Enrollment
Japan
|
2 Participants
n=233 Participants
|
3 Participants
n=235 Participants
|
5 Participants
n=468 Participants
|
|
Region of Enrollment
United Kingdom
|
8 Participants
n=233 Participants
|
0 Participants
n=235 Participants
|
8 Participants
n=468 Participants
|
|
Region of Enrollment
Portugal
|
4 Participants
n=233 Participants
|
5 Participants
n=235 Participants
|
9 Participants
n=468 Participants
|
|
Region of Enrollment
Spain
|
11 Participants
n=233 Participants
|
12 Participants
n=235 Participants
|
23 Participants
n=468 Participants
|
|
Region of Enrollment
Canada
|
7 Participants
n=233 Participants
|
11 Participants
n=235 Participants
|
18 Participants
n=468 Participants
|
|
Region of Enrollment
South Korea
|
1 Participants
n=233 Participants
|
2 Participants
n=235 Participants
|
3 Participants
n=468 Participants
|
|
Region of Enrollment
Turkey
|
1 Participants
n=233 Participants
|
1 Participants
n=235 Participants
|
2 Participants
n=468 Participants
|
|
Region of Enrollment
Taiwan
|
17 Participants
n=233 Participants
|
23 Participants
n=235 Participants
|
40 Participants
n=468 Participants
|
|
Region of Enrollment
Brazil
|
3 Participants
n=233 Participants
|
5 Participants
n=235 Participants
|
8 Participants
n=468 Participants
|
|
Region of Enrollment
Poland
|
12 Participants
n=233 Participants
|
7 Participants
n=235 Participants
|
19 Participants
n=468 Participants
|
|
Region of Enrollment
Italy
|
1 Participants
n=233 Participants
|
1 Participants
n=235 Participants
|
2 Participants
n=468 Participants
|
|
Region of Enrollment
Mexico
|
24 Participants
n=233 Participants
|
24 Participants
n=235 Participants
|
48 Participants
n=468 Participants
|
|
Region of Enrollment
South Africa
|
15 Participants
n=233 Participants
|
16 Participants
n=235 Participants
|
31 Participants
n=468 Participants
|
|
Region of Enrollment
Bulgaria
|
97 Participants
n=233 Participants
|
99 Participants
n=235 Participants
|
196 Participants
n=468 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=233 Participants
|
1 Participants
n=235 Participants
|
1 Participants
n=468 Participants
|
|
Baseline Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load
|
6.15 log10 copies/mL
STANDARD_DEVIATION 1.629 • n=218 Participants • The Safety Analysis Set included all participants who received at least 1 dose of study drug with data available were analyzed. One participant randomized to placebo arm received obeldesivir and was counted in obeldesivir group for the analysis of this baseline measure.
|
6.15 log10 copies/mL
STANDARD_DEVIATION 1.622 • n=215 Participants • The Safety Analysis Set included all participants who received at least 1 dose of study drug with data available were analyzed. One participant randomized to placebo arm received obeldesivir and was counted in obeldesivir group for the analysis of this baseline measure.
|
6.15 log10 copies/mL
STANDARD_DEVIATION 1.624 • n=433 Participants • The Safety Analysis Set included all participants who received at least 1 dose of study drug with data available were analyzed. One participant randomized to placebo arm received obeldesivir and was counted in obeldesivir group for the analysis of this baseline measure.
|
PRIMARY outcome
Timeframe: Up to Day 29Population: The Full Analysis Positive Set included all randomized participants who received at least 1 dose of study drug and were SARS-CoV-2 positive at baseline as confirmed by cepheid's xpert xpress coronavirus-2/flu/respiratory syncytial virus plus test or SARS-CoV-2 reverse transcriptase quantitative polymerase chain reaction test from the central laboratory.
COVID-19-related hospitalization was defined as ≥ 24 hours of acute care for a reason related to COVID-19, in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with COVID-19. This included specialized acute medical care units within an assisted living facility or nursing home. This did not include hospitalization for the purposes of public health and/or clinical trial execution. The date and duration of hospital admission, and primary reason for hospitalization (including if the hospitalization was related to COVID-19) were recorded. Percentages were rounded off.
Outcome measures
| Measure |
Obeldesivir
n=211 Participants
Participants received obeldesivir 350 mg orally twice daily for 5 days.
|
Placebo
n=207 Participants
Participants received placebo-to-match obeldesivir orally twice daily for 5 days.
|
|---|---|---|
|
Percentage of Participants With Coronavirus Disease 2019 (COVID-19) Related Hospitalization or All-Cause Death by Day 29
|
0 percentage of participants
|
0.5 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to 5 Days plus 30 DaysPopulation: The Safety Analysis Set included all participants who received at least 1 dose of study drug. One participant randomized to placebo arm received obeldesivir and was counted in obeldesivir group for the analysis of this outcome measure.
TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug. Any AEs leading to premature discontinuation of study drug. Percentages were rounded off.
Outcome measures
| Measure |
Obeldesivir
n=234 Participants
Participants received obeldesivir 350 mg orally twice daily for 5 days.
|
Placebo
n=231 Participants
Participants received placebo-to-match obeldesivir orally twice daily for 5 days.
|
|---|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAE)
|
22.2 percentage of participants
|
20.8 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to 5 Days plus 30 DaysPopulation: Participants from the Safety Analysis Set who had available post baseline data were analyzed. One participant randomized to placebo arm received obeldesivir and was counted in obeldesivir group for the analysis of this outcome measure.
Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days. Percentages were rounded off.
Outcome measures
| Measure |
Obeldesivir
n=230 Participants
Participants received obeldesivir 350 mg orally twice daily for 5 days.
|
Placebo
n=227 Participants
Participants received placebo-to-match obeldesivir orally twice daily for 5 days.
|
|---|---|---|
|
Percentage of Participants Experiencing Laboratory Abnormalities
Any grade
|
56.1 percentage of participants
|
61.7 percentage of participants
|
|
Percentage of Participants Experiencing Laboratory Abnormalities
Grade 3 or 4
|
6.5 percentage of participants
|
4.8 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to 5 Days plus 30 DaysPopulation: Participants in the Safety Analysis Set were analyzed. One participant randomized to placebo arm received obeldesivir and was counted in obeldesivir group for the analysis of this outcome measure.
A treatment emergent AE is defined as an AE that occurs or worsens in severity on or after the date of the first dose of study drug but no later than 30 days after the permanent discontinuation of study drug or an AE leading to discontinuation of study drug. A SAE is defined as an event that, at any dose, resulted in any of the following: death, life-threatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or a medically important event or reaction. Percentages were rounded off.
Outcome measures
| Measure |
Obeldesivir
n=234 Participants
Participants received obeldesivir 350 mg orally twice daily for 5 days.
|
Placebo
n=231 Participants
Participants received placebo-to-match obeldesivir orally twice daily for 5 days.
|
|---|---|---|
|
Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation
AEs Leading to Study Drug Discontinuation
|
1.7 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation
SAEs Leading to Study Drug Discontinuation
|
0.9 percentage of participants
|
0.9 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Participants in the Full Analysis Positive Set were analyzed.
All-cause hospitalization was defined as ≥ 24 hours of acute care, in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with COVID-19. This includes specialized acute medical care units within an assisted living facility or nursing home. This does not include hospitalization for the purposes of public health and/or clinical study execution. The date and duration of hospital admission, and primary reason for hospitalization (including if the hospitalization is related to COVID-19) were recorded. Percentages were rounded off.
Outcome measures
| Measure |
Obeldesivir
n=211 Participants
Participants received obeldesivir 350 mg orally twice daily for 5 days.
|
Placebo
n=207 Participants
Participants received placebo-to-match obeldesivir orally twice daily for 5 days.
|
|---|---|---|
|
Percentage of Participants With All-Cause Hospitalization by Day 29
|
0.5 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Participants in the Full Analysis Positive Set were analyzed.
Medically attended visits were defined as interactions with health care professionals other than study staff or designees including hospitalization; in-person emergency, urgent, or primary care visits; or any other in-person visit attended by the participant and a health care professional. The nature and cause of the visit were identified. KM estimates were used in the outcome measure analysis. Percentages were rounded off.
Outcome measures
| Measure |
Obeldesivir
n=211 Participants
Participants received obeldesivir 350 mg orally twice daily for 5 days.
|
Placebo
n=207 Participants
Participants received placebo-to-match obeldesivir orally twice daily for 5 days.
|
|---|---|---|
|
Percentage of Participants With COVID-19-Related Medically Attended Visits (MAVs) or All-Cause Death by Day 29
|
1.0 percentage of participants
|
1.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Participants in the Full Analysis Positive Set were analyzed.
Medically attended visits were defined as interactions with health care professionals other than study staff or designees including hospitalization; in-person emergency, urgent, or primary care visits; or any other in-person visit attended by the participant and a health care professional. The nature and cause of the visit were identified. KM estimates were used in the outcome measure analysis. Percentages were rounded off.
Outcome measures
| Measure |
Obeldesivir
n=211 Participants
Participants received obeldesivir 350 mg orally twice daily for 5 days.
|
Placebo
n=207 Participants
Participants received placebo-to-match obeldesivir orally twice daily for 5 days.
|
|---|---|---|
|
Percentage of Participants With COVID-19-Related MAVs by Day 29
|
1 percentage of participants
|
0.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Participants in the Full Analysis Positive Set were analyzed.
Percentages were rounded off.
Outcome measures
| Measure |
Obeldesivir
n=211 Participants
Participants received obeldesivir 350 mg orally twice daily for 5 days.
|
Placebo
n=207 Participants
Participants received placebo-to-match obeldesivir orally twice daily for 5 days.
|
|---|---|---|
|
Percentage of Participants With All-cause Death by Day 29
|
0 percentage of participants
|
0.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 15Population: Participants in the Full Analysis Positive Set with Covid19 symptoms who completed Symptoms of Infection With Coronavirus-19 at baseline were analyzed.
Time to COVID-19 symptom alleviation was calculated as symptom alleviation date/time minus the first dose date/time. Symptom alleviation was evaluated for the 15 targeted symptoms using symptoms of infection with coronavirus-19 (SIC) questionnaire. The SIC questionnaire assessed all targeted symptoms, alleviation was defined as the SIC rating of 0, or at least 3 points decrease in rating from baseline, or an answer "No" to the question for at least 48 consecutive hours.
Outcome measures
| Measure |
Obeldesivir
n=84 Participants
Participants received obeldesivir 350 mg orally twice daily for 5 days.
|
Placebo
n=78 Participants
Participants received placebo-to-match obeldesivir orally twice daily for 5 days.
|
|---|---|---|
|
Time to COVID-19 Symptom Alleviation by Day 15
|
7.3 Days
Interval 5.4 to 9.4
|
9.3 Days
Interval 6.5 to
Upper limit of CI did not reach due to low number of participants with events.
|
SECONDARY outcome
Timeframe: Day 5Population: Virology Analysis Set included all randomized participants who received at least 1 dose of study drug and had baseline SARS-CoV-2 viral load greater than or equal to lower limit of quantitation.
The mixed model for repeated measures (MMRM) was used for analysis.
Outcome measures
| Measure |
Obeldesivir
n=193 Participants
Participants received obeldesivir 350 mg orally twice daily for 5 days.
|
Placebo
n=192 Participants
Participants received placebo-to-match obeldesivir orally twice daily for 5 days.
|
|---|---|---|
|
Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5
|
-2.80 log10 copies/mL
Standard Error 0.092
|
-2.22 log10 copies/mL
Standard Error 0.092
|
SECONDARY outcome
Timeframe: Day 1, 0.75 and 2 hours postdose and Day 5 predose and 0.75 hours postdosePopulation: Pharmacokinetic Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least 1 non missing concentration value reported by the PK laboratory with available data were analyzed .
Outcome measures
| Measure |
Obeldesivir
n=224 Participants
Participants received obeldesivir 350 mg orally twice daily for 5 days.
|
Placebo
Participants received placebo-to-match obeldesivir orally twice daily for 5 days.
|
|---|---|---|
|
Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)
Day 5, 0.75 hours postdose
|
3089.09 ng/mL
Standard Deviation 1839.992
|
—
|
|
Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)
Day 1, 0.75 hours postdose
|
2330.42 ng/mL
Standard Deviation 1709.560
|
—
|
|
Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)
Day 1, 2 hours postdose
|
2535.84 ng/mL
Standard Deviation 1370.131
|
—
|
|
Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)
Day 5, Predose
|
1116.81 ng/mL
Standard Deviation 1101.371
|
—
|
Adverse Events
Obeldesivir
Placebo
Serious adverse events
| Measure |
Obeldesivir
n=234 participants at risk
Participants received obeldesivir 350 mg orally twice daily for 5 days.
|
Placebo
n=231 participants at risk
Participants received placebo-to-match obeldesivir orally twice daily for 5 days.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/234 • All-cause mortality, Adverse events: First dose date up to 5 Days plus 30 Days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. One participant randomized to placebo arm accidentally received obeldesivir and was counted in obeldesivir group for the analysis of all-cause mortality and adverse events. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.43%
1/231 • All-cause mortality, Adverse events: First dose date up to 5 Days plus 30 Days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. One participant randomized to placebo arm accidentally received obeldesivir and was counted in obeldesivir group for the analysis of all-cause mortality and adverse events. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Death
|
0.00%
0/234 • All-cause mortality, Adverse events: First dose date up to 5 Days plus 30 Days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. One participant randomized to placebo arm accidentally received obeldesivir and was counted in obeldesivir group for the analysis of all-cause mortality and adverse events. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.43%
1/231 • All-cause mortality, Adverse events: First dose date up to 5 Days plus 30 Days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. One participant randomized to placebo arm accidentally received obeldesivir and was counted in obeldesivir group for the analysis of all-cause mortality and adverse events. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.43%
1/234 • All-cause mortality, Adverse events: First dose date up to 5 Days plus 30 Days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. One participant randomized to placebo arm accidentally received obeldesivir and was counted in obeldesivir group for the analysis of all-cause mortality and adverse events. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/231 • All-cause mortality, Adverse events: First dose date up to 5 Days plus 30 Days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. One participant randomized to placebo arm accidentally received obeldesivir and was counted in obeldesivir group for the analysis of all-cause mortality and adverse events. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.43%
1/234 • All-cause mortality, Adverse events: First dose date up to 5 Days plus 30 Days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. One participant randomized to placebo arm accidentally received obeldesivir and was counted in obeldesivir group for the analysis of all-cause mortality and adverse events. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/231 • All-cause mortality, Adverse events: First dose date up to 5 Days plus 30 Days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. One participant randomized to placebo arm accidentally received obeldesivir and was counted in obeldesivir group for the analysis of all-cause mortality and adverse events. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
Other adverse events
Adverse event data not reported
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER