Сlinical Trial of Efficacy and Safety of Prospekta in the... | NCT05074888

NCT05074888

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Detailed Description

Design: the multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical trial.

The study will enroll adult patients of either gender aged 18 to 65 years after new coronavirus infection of 2019 (COVID-19) with symptoms of asthenia that appeared during or after an acute coronavirus infection (COVID-19) and persisting 4 to 12 weeks from the onset of coronavirus infection.

After the patient signs the patient information sheet and the informed consent form for participation in the study, complaints, medical history, physical examination, registration of vital signs are collected, the patient fills in the Fatigue Severity Scale (FSS) and Hospital Anxiety and Depression Scale (HADS). A six-minute walk test (6MWT) is carried out. The physician evaluates the severity of asthenia with FSS scale and records concomitant medications, co-morbidities and concurrent conditions.

If a patient meets all inclusion criteria and does not have any of the exclusion criteria at Visit 1 (Day 1), he/she is randomized to one of two groups: Group 1 - patients receive Prospekta at a dose of 1 tablet twice daily for 4 weeks; Group 2 - patients receive placebo on the study drug regimen.

The trial will use electronic patient diaries (EPD). The patient should record any possible deterioration (if applicable) in the EPD. At Visit 1 (Day 1), the physician will provide guidance on how to work with EPD, so that the patient can use it independently in the future.

At Visit 2 (Week 4 ± 3 days), the physician will collect patient's complaints, record physical examination data and vital signs as well as any changes in concurrent diseases and conditions. The patient fills out the FSS and HADS scales. A 6MWT is carried out. The physician monitors the prescribed treatment and use of concomitant medications, evaluates the safety of the study treatment and patient's compliance, filling out the diary.

The patient stops taking the study drug. At the end of the study treatment period, the patient is monitored for 4 weeks (follow-up period).

At Visit 3 (final visit, Week 8 ± 3 days), the physician collects patient's complaints, records physical examination data and vital signs, changes in concomitant diseases and conditions. The patient fills in the FSS and HADS scales. A 6MWT is carried out. The physician evaluates the safety of the study treatment, checks the completion of the diary.

During the study the patients are allowed to take medications for their chronic conditions, except for medicines listed as "Prohibited concomitant treatment".

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prospekta	Experimental	Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved.	Drug: Prospekta
Placebo	Placebo Comparator	Tablet for oral use. Placebo using Prospekta scheme.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Prospekta	Drug	Oral administration.	Prospekta
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in the Mean FSS Score.	Fatigue Severity Scale (FSS). Change in the mean FSS score after 4 weeks of treatment. The total score of the scale, which consists of 9 questions, varies between 9-63. This scale consists of a 7-point Likert scale. 1 point means strongly disagree, 7 means strongly agree. People are asked to mark the appropriate options for each question taking into account their status in the last 1 month period. A total of 36 points and above indicate fatigue. A higher score is indicated high level of fatigue.	after 4 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
Change in Distance of the 6-minute Walk Test.	Change in distance when performing the 6-minute walk test after 4 weeks of treatment. The test is carried out with the aim of objectively assessing the patient's physical tolerance. The patient should walk the maximum possible distance for himself at his own pace on a flat surface in 6 minutes.	after 4 weeks of treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults of either gender aged 18 to 65 years inclusive.
Patients within 4-12 weeks of the confirmed COVID-19 onset .
Symptoms of asthenia that appeared during or after an acute new coronavirus infection (COVID-19), persisting from 4 to 12 weeks from the onset of coronavirus infection.
Presence of asthenia (≥36 on the FSS scale).
Patients who agreed to use a reliable method of contraception during the study (for men and women with reproductive potential).
Presence of a signed information sheet and informed consent form for participation in a clinical trial.

Exclusion Criteria:

History / suspicion of cancer of any localization (with the exception of benign neoplasms).
More than 75% of lung tissue damage during the period of COVID-19 disease (CT 4).
Cerebrovascular diseases with the development of moderate to severe cognitive impairments.
Uncontrolled arterial hypertension characterized by the following blood tension values: systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 110 mm Hg.
Myocardial infarction, stroke in the previous 6 months.
Nervous system disorders with persistent neurological impairment.
Autoimmune diseases.
Decompensated diseases of the cardiovascular system, liver, kidney, gastrointestinal tract, and metabolic, respiratory, endocrine or hematological diseases, peripheral vascular disorders.
Any severe comorbidity which, in the opinion of the investigator, may affect patient participation in the clinical trial.
Hypersensitivity to any of the components of the study drug.
Hereditary lactose intolerance, lactose malabsorption, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial (for men and women with reproductive potential).
Patients, who, from the investigator's point of view, will not comply with study observation requirements or study drug administration procedures..
Prior history of mental illness, alcoholism or drug abuse, that the investigator's opinion, will interfere with successful study procedures.
Use of any medications listed in "Prohibited concomitant treatment" within 1 week before enrollment.
Participation in other clinical studies within 3 months prior to enrollment in the study.
Patients who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. "Immediate relative" means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).
Participants who work for OOO "NPF "MATERIA MEDICA HOLDING" (i.e. the company's employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Belgorod Regional Clinical Hospital of St. Joasaph		Belgorod		308007	Russia
Clinical hospital "RZD-Medicine" of Chelyabinsk city

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Prospekta	Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved. Prospekta: Oral administration.
FG001	Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 16, 2021

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Prospekta	Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved. Prospekta: Oral administration.
BG001	Placebo	Tablet for oral use. Placebo using Prospekta scheme. Placebo: Oral administration.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Baseline

Title	Measurements
	OG00046.4± 6.9 OG00145.9± 6.6

After 4 weeks

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	This analysis applies to ∆ between baseline and 4 weeks later row.	Wilcoxon (Mann-Whitney)		0.0016														Superiority

Secondary

Change in Distance of the 6-minute Walk Test.

Change in distance when performing the 6-minute walk test after 4 weeks of treatment. The test is carried out with the aim of objectively assessing the patient's physical tolerance. The patient should walk the maximum possible distance for himself at his own pace on a flat surface in 6 minutes.

Posted

Mean

Standard Deviation

meters

after 4 weeks of treatment

ID	Title	Description
OG000	Prospekta	Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved. Prospekta: Oral administration.
OG001	Placebo	Tablet for oral use. Placebo using Prospekta scheme. Placebo: Oral administration.

Units	Counts
Participants	OG000

Secondary

Change in the Severity of Anxiety on the HADS Subscale.

Hospital Anxiety and Depression Scale (HADS). Change in the severity of anxiety and depression on the HADS subscales after 4 weeks of treatment. The scale is composed of 14 statements serving 2 subscales: "anxiety" (odd items - 1, 3, 5, 7, 9, 11, 13) and "depression" (even items - 2, 4, 6, 8, 10, 12 , 14). Each statement corresponds to 4 answer options, reflecting the gradation of the severity of the sign and coded according to the increase in the severity of the symptom from 0 (no) to 3 (maximum severity). When interpreting the results, the total indicator for each subscale is taken into account, while there are 3 areas of its values:

0-7 - "norm" (absence of reliably expressed symptoms of anxiety and depression); 8-10 - "subclinical anxiety / depression"; 11 and above - "clinical anxiety / depression". The anxiety subscale ranges from 0 to 21, with higher values reflecting a worse outcome.

Posted

Mean

Standard Deviation

score on a scale

after 4 weeks of treatment

ID	Title	Description
OG000	Prospekta	Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved. Prospekta: Oral administration.
OG001	Placebo	Tablet for oral use. Placebo using Prospekta scheme. Placebo: Oral administration.

Secondary

Change in the Severity of Depression on the HADS Subscale.

Hospital Anxiety and Depression Scale (HADS). Change in the severity of depression on the HADS subscale after 4 weeks of treatment. The scale is composed of 14 statements serving 2 subscales: "anxiety" (odd items - 1, 3, 5, 7, 9, 11, 13) and "depression" (even items - 2, 4, 6, 8, 10, 12 , 14). Each statement corresponds to 4 answer options, reflecting the gradation of the severity of the sign and coded according to the increase in the severity of the symptom from 0 (no) to 3 (maximum severity). When interpreting the results, the total indicator for each subscale is taken into account, while there are 3 areas of its values:

0-7 - "norm" (absence of reliably expressed symptoms of anxiety and depression); 8-10 - "subclinical anxiety / depression"; 11 and above - "clinical anxiety / depression". The depression subscale ranges from 0 to 21, with higher values reflecting a worse outcome.

Posted

Mean

Standard Deviation

score on a scale

after 4 weeks of treatment

ID	Title	Description
OG000	Prospekta	Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved. Prospekta: Oral administration.
OG001	Placebo	Tablet for oral use. Placebo using Prospekta scheme. Placebo: Oral administration.

Secondary

Change in the Mean FSS Score Within Follow-up Period.

Change in mean FSS score over 4 weeks of follow-up period at the end of treatment. The total score of the scale, which consists of 9 questions, varies between 9-63. This scale consists of a 7-point Likert scale. 1 point means strongly disagree, 7 means strongly agree. People are asked to mark the appropriate options for each question taking into account their status in the last 1 month period. A total of 36 points and above indicate fatigue. A higher score is indicated high level of fatigue.

One patient in Prospekta group was excluded from the trial before finishing follow-up period therefore no data was collected within 4 weeks of follow-up.

Posted

Mean

Standard Deviation

score on a scale

after 4 weeks of treatment and after 4 weeks of follow-up at week 8

ID	Title	Description
OG000	Prospekta	Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved. Prospekta: Oral administration.
OG001	Placebo	Tablet for oral use. Placebo using Prospekta scheme. Placebo: Oral administration.

Secondary

Change in Distance of the 6-minute Walk Test Within Follow-up Period.

Change in distance when performing the 6-minute walk test over a 4-week follow-up period at the end of treatment. The test is carried out with the aim of objectively assessing the patient's physical tolerance. The patient should walk the maximum possible distance for himself at his own pace on a flat surface in 6 minutes.

One patient in Prospekta group and three patients in Placebo group were excluded from the trial before finishing follow-up period therefore no data was collected within 4 weeks of follow-up.

Posted

Mean

Standard Deviation

meter

after 4 weeks of treatment and after 4 weeks of follow-up at week 8

ID	Title	Description
OG000	Prospekta	Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved. Prospekta: Oral administration.
OG001	Placebo	Tablet for oral use. Placebo using Prospekta scheme. Placebo: Oral administration.

Units	Counts
Participants

Secondary

Change in the Severity of Anxiety on the HADS Subscales Within Follow-up Period.

Change in the severity of anxiety on the HADS subscales over a 4-week follow-up period at the end of treatment. The scale is composed of 14 statements serving 2 subscales: "anxiety" (odd items - 1, 3, 5, 7, 9, 11, 13) and "depression" (even items - 2, 4, 6, 8, 10, 12 , 14). Each statement corresponds to 4 answer options, reflecting the gradation of the severity of the sign and coded according to the increase in the severity of the symptom from 0 (no) to 3 (maximum severity). When interpreting the results, the total indicator for each subscale is taken into account, while there are 3 areas of its values:

One patient in Prospekta group and three patients in Placebo group were excluded from the trial before finishing follow-up period therefore no data was collected within 4 weeks of follow-up.

Posted

Mean

Standard Deviation

score on a scale

after 4 weeks of treatment and after 4 weeks of follow-up at week 8

ID	Title	Description
OG000	Prospekta	Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved. Prospekta: Oral administration.
OG001	Placebo

Secondary

Change in the Severity of Depression on the HADS Subscales Within Follow-up Period.

Change in the severity of depression on the HADS subscales over a 4-week follow-up period at the end of treatment.

The scale is composed of 14 statements serving 2 subscales: "anxiety" (odd items - 1, 3, 5, 7, 9, 11, 13) and "depression" (even items - 2, 4, 6, 8, 10, 12 , 14). Each statement corresponds to 4 answer options, reflecting the gradation of the severity of the sign and coded according to the increase in the severity of the symptom from 0 (no) to 3 (maximum severity). When interpreting the results, the total indicator for each subscale is taken into account, while there are 3 areas of its values:

One patient in Prospekta group and three patients in Placebo group were excluded from the trial before finishing follow-up period therefore no data was collected within 4 weeks of follow-up.

Posted

Mean

Standard Deviation

score on a scale

after 4 weeks of treatment and after 4 weeks of follow-up at week 8

ID	Title	Description
OG000	Prospekta	Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved. Prospekta: Oral administration.
OG001

Secondary

Changes in Vital Signs (Pulse Rate (Heart Rate)).

Based on medical records. Vital signs will be measured in a medical setting.

Lower patient count is due to missing data on visits 2 and 3.

Posted

Mean

Standard Deviation

beats per minute

after 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment.

ID	Title	Description
OG000	Prospekta	Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved. Prospekta: Oral administration.
OG001	Placebo	Tablet for oral use. Placebo using Prospekta scheme. Placebo: Oral administration.

Units	Counts
Participants	OG000

Secondary

Changes in Vital Signs (Respiration Rate (Breathing Rate)).

Based on medical records. Vital signs will be measured in a medical setting.

Lower patient count is due to missing data on visits 2 and 3.

Posted

Mean

Standard Deviation

breaths per minute

after 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment (Visit 1: baseline, Visit 2: after 4 weeks of treatment, and Visit 3: after 4 weeks of follow-up at week 8)

ID	Title	Description
OG000	Prospekta	Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved. Prospekta: Oral administration.
OG001	Placebo	Tablet for oral use. Placebo using Prospekta scheme. Placebo: Oral administration.

Units	Counts
Participants	OG000

Secondary

Changes in Vital Signs (Blood Pressure).

Based on medical records. Vital signs will be measured in a medical setting.

Lower patient count is due to missing data on visits 2 and 3.

Posted

Mean

Standard Deviation

mmHg

ID	Title	Description
OG000	Prospekta	Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved. Prospekta: Oral administration.
OG001	Placebo	Tablet for oral use. Placebo using Prospekta scheme. Placebo: Oral administration.

Units	Counts
Participants	OG000

Secondary

Presence of Adverse Events (AEs).

The number of participants with adverse events (AEs). Based on medical records.

Posted

Count of Participants

Participants

8 weeks

ID	Title	Description
OG000	Prospekta	Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved. Prospekta: Oral administration.
OG001	Placebo	Tablet for oral use. Placebo using Prospekta scheme. Placebo: Oral administration.

Units	Counts
Participants	OG000

Secondary

The Severity of AEs.

The intensity (severity) of adverse events. Based on medical records.

Posted

Number

number of AEs

8 weeks

ID	Title	Description
OG000	Prospekta	Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved. Prospekta: Oral administration.
OG001	Placebo	Tablet for oral use. Placebo using Prospekta scheme. Placebo: Oral administration.

Units	Counts
Participants	OG000

Secondary

The Outcome of AEs.

The outcome of adverse events. Based on medical records.

Posted

Number

number of AEs

8 weeks

ID	Title	Description
OG000	Prospekta	Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved. Prospekta: Oral administration.
OG001	Placebo	Tablet for oral use. Placebo using Prospekta scheme. Placebo: Oral administration.

Units	Counts
Participants	OG000

Secondary

AEs Causal Relationship to the Study Drug.

The adverse events causal relationship to the study drug. Based on medical records.

Posted

Number

number of AEs

8 weeks

ID	Title	Description
OG000	Prospekta	Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved. Prospekta: Oral administration.
OG001	Placebo	Tablet for oral use. Placebo using Prospekta scheme. Placebo: Oral administration.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Prospekta	Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved. Prospekta: Oral administration.	0	330	0	330	20	330
EG001	Placebo	Tablet for oral use. Placebo using Prospekta scheme. Placebo: Oral administration.	0	346	0	346	20	346

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected330 at risk EG0011 events1 affected346 at risk
Epigastric pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected330 at risk EG0011 events1 affected346 at risk
Diarrhea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected330 at risk EG0011 events1 affected346 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected330 at risk EG0010 events0 affected346 at risk
Stomach cramps	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected330 at risk EG0011 events1 affected346 at risk
Dry mouth	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected330 at risk EG0010 events0 affected346 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected330 at risk EG0011 events1 affected346 at risk
Viral infection of the respiratory tract	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected330 at risk EG0011 events1 affected346 at risk
Herpes	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected330 at risk EG0011 events1 affected346 at risk
Laboratory confirmed coronavirus infection COVID-19	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected330 at risk EG0012 events2 affected346 at risk
Acute respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected330 at risk EG0010 events0 affected346 at risk
Acute rhinitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected330 at risk EG0010 events0 affected346 at risk
Rhinitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected330 at risk EG0011 events1 affected346 at risk
BP above normal	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected330 at risk EG0011 events1 affected346 at risk
Food allergy	Immune system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected330 at risk EG0011 events1 affected346 at risk
Lumbar spine pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected330 at risk EG0010 events0 affected346 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected330 at risk EG0010 events0 affected346 at risk
Dorsopathy	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected330 at risk EG0010 events0 affected346 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected330 at risk EG0010 events0 affected346 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 events3 affected330 at risk EG0014 events4 affected346 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected330 at risk EG0013 events3 affected346 at risk
Root lumbar pain	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected330 at risk EG0011 events1 affected346 at risk
Upper limb numbness	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected330 at risk EG0010 events0 affected346 at risk
Sensory disorder	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected330 at risk EG0011 events1 affected346 at risk
Drowsiness	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected330 at risk EG0010 events0 affected346 at risk
Cephalalgia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected330 at risk EG0011 events1 affected346 at risk
Ovarian hemorrhage	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 events0 affected330 at risk EG0011 events1 affected346 at risk
Hypertensive crisis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected330 at risk EG0010 events0 affected346 at risk
Worsening of hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0002 events2 affected330 at risk EG0010 events0 affected346 at risk
Flu-like symptoms	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected330 at risk EG0011 events1 affected346 at risk
Precardial pain	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected330 at risk EG0010 events0 affected346 at risk
Mucosal dryness	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected330 at risk EG0011 events1 affected346 at risk
Residual taste after drug administration	Product Issues	MedDRA	Systematic Assessment	EG0000 events0 affected330 at risk EG0011 events1 affected346 at risk
Insomnia	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected330 at risk EG0011 events1 affected346 at risk
Nightmares	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected330 at risk EG0010 events0 affected346 at risk
Tearfulness	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected330 at risk EG0010 events0 affected346 at risk
Back contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected330 at risk EG0011 events1 affected346 at risk

ID	Term
D000094024	Post-Acute COVID-19 Syndrome

Ancestor Terms

ID	Term
D000086382	COVID-19
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases
D018352	Coronavirus Infections
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D000094025	Post-Infectious Disorders
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Units	Counts
Participants	OG000326 OG001343

Units	Counts
Participants	OG000327 OG001343